Self-expanding devices and methods therefor

ABSTRACT

Described here are self-expanding devices and methods of using and making them. The devices may be useful in a variety of locations within the body, for a number of different uses. In some variations, the devices have a first compressed configuration enabling low profile delivery through a delivery device, a second expanded configuration for apposition against tissue, and comprise either a single continuous filament or at least two non-intersecting filaments. In some variations, the device is formed into a shape having a series of peaks and valleys. At least one of the peaks and valleys may have a loop at then end thereof. At least a portion of these devices may be capable of biodegrading over a predetermined period of time, and the devices may be configured for drug delivery. Methods of treating one or more sinus cavities are also described here.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 61/014,653, filed on Dec. 18, 2007, and to U.S. ProvisionalApplication Ser. No. 61/058,803, filed on Jun. 4, 2008, each of which ishereby incorporated by reference in its entirety.

FIELD

The present invention relates generally to delivery devices fordelivering one or more implants to or near a paranasal sinus. At least aportion of these implants may be self-expanding, and at least a portionof the implants may be biodegradable and configured for drug delivery.Methods of using the delivery devices are also described here.

BACKGROUND

Self-expanding devices may be useful in maintaining, opening or dilatingbodily structures such as veins, arteries, ureters, urethras,hollow-body organs, nasal passages, sinus cavities, and the like. Giventhe variety of benefits these devices may provide, additionalself-expanding devices would be desirable. In particular, self-expandingdevices that may offer advantageous physical and/or functionalcharacteristics would be desirable. Additionally, delivery devices fordelivering self-expanding devices and other implants would be desirable.

BRIEF SUMMARY

Described here are self-expanding devices, and methods of using andmaking them. The devices may be useful in a variety of locations withinthe body for a number of different uses. In some variations, the deviceshave a first compressed configuration enabling low profile deliverythrough a delivery device, a second expanded configuration forapposition against tissue, and comprise either a single continuousfilament or at least two non-intersecting filaments. In othervariations, the device comprises two or more filaments that areintersecting, joined, or contacting (e.g., in an overlapping, twisted,knotted, or bonded fashion). At least a portion of these devicestypically comprises a polymer, e.g., a biodegradable polymer. Ininstances where a biodegradable polymer is used, the device (or aportion thereof) is typically capable of biodegrading over apredetermined period of time. The polymer may be any suitable or usefulpolymer, and the device may include or comprise any additional suitablematerials. In some variations, for example, the devices comprise atleast one metallic filament, at least one flexible section, or the like.

In some variations, the devices are suitable for drug delivery. In thesevariations, the polymer or at least a portion of the device may becoated or impregnated with a drug, be at least partially coated with adrug eluting layer, or comprise one or more drug depots. A drug may beconfigured to be released from the drug eluting layer or depot over aperiod of time, e.g., from about 5 days to about 120 days, or evenlonger. Any suitable drug or agent may be used, and in some variationsmore than one drug or agent is used. For example, multiple drugs may beconfigured to be released from a single drug eluting layer, or multipledrug eluting layers may be configured to release multiple drugs. Thedrug or agent may be an anti-inflammatory agent, an anti-allergen, ananti-cholinergic agent, an antihistamine, an anti-infective, ananti-platelet agent, an anti-coagulant, an anti-thrombic agent, ananti-scarring agent, an anti-proliferative agent, a chemotherapeuticagent, an anti-neoplastic agent, a pro-healing agent, a decongestant, avitamin, a hypersomolar agent, an immunomodulator, an immunosuppressiveagent, or combinations and mixtures thereof. In some variations, thedrug is an anti-inflammatory, e.g., mometasone furoate. The drug elutinglayer may be discontinuous and may comprise a release rate modifier. Insome variations, the release rate modifier is a polyethylene glycol,e.g., PEG 6000.

Some of the devices described here have a size and configuration adaptedfor implantation within one or more sinus cavities or sinus regions,e.g., an ethmoid sinus cavity, a maxillary sinus cavity, a frontal sinuscavity, a sphenoid sinus cavity, the osteomeatal complex, the nasalpassage, or combinations thereof. However, as described above, thedevices may be useful within any hollow-body organ (throat, biliaryduct, organ or passageway of the excretory system, etc.) or cavity oreven within the vasculature.

In some variations, self-expanding devices are described having a firstcompressed configuration enabling low profile delivery through adelivery device, and a second expanded configuration for appositionagainst tissue, where at least a portion of the device comprises abiodegradable material and the device is formed into a shape having aseries of peaks and valleys. In other variations, the device is formedinto a shape having at least two series of peaks and/or valleys. In somevariations, the shape of the device comprises a diamond-shaped,arrowhead-shaped, or rectangular pattern. Some variations furthercomprise junctions.

At least one of the peaks and valleys may have a loop at an end thereof.The loop may or may not be coated or impregnated with a drug or with apolymer for delivery of a drug therefrom. When a loop is used, it may beconfigured to provide for even distribution of bending stresses (e.g.,stresses applied to the device when the device is placed in its firstconfiguration and loaded into a delivery device). The loop may compriseor define an eyelet for passage of a suture therethrough, e.g., so thatwhen the suture is pulled, the device collapses from its secondconfiguration to its first configuration. The angle defined by the loopapex may be of any suitable degree, for example, it may be from about30° to about 150° when the device is in its expanded configuration. Insome variations, the angle is about 75°.

In some variations, a portion of the devices or a portion of the polymeris at least partially coated with a drug or drug eluting layer. Thepolymer and the drug eluting layer may comprise PLG with different molarratios of lactide to glycolide. As with the devices described justabove, any suitable drug or agent may be delivered and selection of sucha drug or agent is largely determined based upon the desired use of thedevice. In addition, as described above, multiple drugs may beconfigured to be released over multiple periods of time from one or moredrug eluting layers. In variations where multiple drugs are released,each drug may or may not be released simultaneously with other drugs. Insome variations, the devices are useful to treat inflammation, and thedrug eluting layer comprises an anti-inflammatory agent.

In other variations, devices are described here having a firstcompressed configuration enabling low profile delivery through adelivery device, and a second expanded configuration for appositionagainst a tissue wall, where the device has a geometry that facilitatesits conformation against an irregular tissue wall. In these variationsthe device defines a lumen (having any suitable cross-sectionalgeometry) in its expanded configuration, which is sized to promoteclearance of one or more fluids therethrough (e.g., mucus or otherdrainage, water, saline, or other irrigation fluid, and the like).

In still other variations, devices are described here having bothunexpanded and expanded configurations, and where the device comprisesat least two component pieces, or a single continuous filament that iswound upon itself. The component pieces may be separate filaments,separate devices, a combination thereof, or the like. In some of thesevariations the at least two component pieces are formed into a shapehaving a series of peaks and valleys. The component pieces may or maynot be joined together, and in variations where they are joined, theymay be joined using welding (e.g., heat welding, ultrasonic welding,tacking, staking, and the like), adhesives (glues, adhesive polymers,and the like), polymers (e.g., low melting-temperature polymers and thelike), sutures, clamps, clips, other mechanical fasteners, chemicalbonding, or some combination thereof. They may also be joined byinterweaving portions of the component pieces. In some variations, theat least two component pieces comprise at least two separate expandabledevices, and in this way, for example, the overall device may bemodular.

In yet other variations, self-expanding biodegradable devices aredescribed having sizes and configurations adapted for implantationwithin one or more sinus regions or sinus cavities or ostiums thereof,where the devices comprise one or more polymer filaments and have shapesthat approximate a repeating diamond-shaped pattern. The diamond-shapedpattern is typically defined by a series of repeating peaks and valleys.In some of these variations, the device may comprise at least twocomponent pieces (devices or filaments, etc.). In some variations thebiodegradable device comprises poly(lactic acid-co-glycolic acid). Aswith the devices described above, the devices of these variations maycomprise junctions formed in any suitable manner and having any suitableconfiguration.

Methods of treating one or more sinus cavities, or one or more locationswhere sinus cavities have been removed, are also described here. Ingeneral, these methods comprise advancing a device adjacent to a sinuscavity and delivering at least a portion of the device within the sinuscavity. The devices are typically biodegradable. In some variations thedevices comprise a polymer at least partially coated with a drug or adrug eluting layer, and are formed into a shape having a series of peaksand valleys. The device may be advanced adjacent to the sinus cavity ina compressed configuration and then delivered or deployed to allowexpansion at least partially within the sinus cavity in any suitablemanner. The device is typically crimped prior to its advancement toenable low profile delivery, and the ratio of the device prior tocrimping and after crimping may be in the range of about 1:1.1-1:20(i.e., for 1:1.1, the diameter of the device prior to crimping is 1.1times the diameter of the device after crimping). The devices useful forthese methods may be any of those devices described just above, or othersimilar such devices having any of the attributes described just above.In variations where the device defines a lumen in its expandingconfiguration, the method may also comprise irrigating one or more sinuscavities.

Methods of making self-expanding devices are also described. In general,the methods comprise extruding a polymer filament, where the polymerfilament comprises PLG having a molar percent of glycolide from about70-100% or a molar percent of lactide from about 70-100%, coating thepolymer filament with a drug eluting layer, and forming the device. Thedevice is typically crimpable from an expanded configuration to adelivery configuration by at least 10%. The method may further comprisecrimping the device, or any additional suitable step.

Also described here are delivery devices and methods for using them. Thedelivery devices may deliver any suitable device or implant, includingthe self-expanding devices described here. In some variations, thedelivery device comprises a handle and a cannula. In some variations,the cannula may have one or more curved section. Each curved section mayhave any suitable angle. In some variations, the angle may be betweenabout 10° and about 120°. In other variations, the angle may be betweenabout 50° and about 120°. In still other variations, the angle may bebetween 10° and about 110°. In some variations the cannula may besteerable. Additionally the cannula may have any suitable number oflumens (e.g. 1, 2, 3, 4, or 5 or more lumens).

Additionally, in some variations the cannula comprises a cannula tipthat has one or more markers. The markers may or may not aid in directvisualization of the cannula tip, and may or may not aid in indirectvisualization of the cannula tip. Furthermore, the cannula tip may haveany suitable configuration of elements. In some variations, the cannulatip may comprise slots and prongs. In some of these variations, theprongs may be directed inwardly. In some of these variations, the prongsmay approximate a point. In other variations, the cannula tip maycomprise a plate extension, an expandable funnel-shaped tip, a bulboustip, a slotted tube, a wedge-shaped tip, a shapeable or deformable tip,combinations thereof and the like.

In some variations the delivery devices may comprise one or moresheathes. In some variations, the sheath is disposed around the outsideof the cannula. In other variations, the sheath is disposed inside ofthe cannula. In some variations, the sheath is releasably attached tothe cannula. The sheath may or may not be configured to release one ormore drugs. Furthermore, in some variations, the delivery device maycomprise one or more dilators or other implants disposed around theoutside of the cannula.

Additionally, in some variations the delivery devices described here maycomprise a deployment mechanism for deploying one or more implants fromthe cannula. In some variations, the deployment mechanism comprises aplunger. In some of these variations, the plunger may comprise one ormore runners. In other variations, the deployment mechanism may compriseone or more stoppers.

Furthermore, the handle may have any suitable configuration of elements.In some variations, the handle may comprise a plunger or trigger thatmay be attached to a deployment mechanism. In other variations, theplunger or trigger may be attached to the cannula. In some variations,the handle may be adjustable. In some of these variations, the handlecomprises one or more adjustable rings. In other variations, the handlecomprises a plunger or trigger having an adjustable length.

Additionally described here are methods for delivering one or moreimplants using the delivery devices described here. In some variations,the methods comprise crimping a self-expanding device from an expandedconfiguration to a compressed configuration, wherein the self-expandingdevice comprises at least two polymer filaments and has a shape thatapproximates a repeating diamond-shaped pattern, the diamond-shapedpattern defined by a series of repeating peaks and valleys, loading thedevice in its compressed configuration into a delivery device comprisinga cannula, wherein the cannula comprises one or more curved sections,advancing the cannula to a paranasal sinus cavity or ositum, anddeploying the self-expanding device to the paranasal sinus cavity orostium such that the self-expanding device expands to its expandedconfiguration. The delivery device may have any feature or combinationof features as described above.

In some variations, the method comprises puncturing one or more tissuesusing the delivery device. In some of these variations, the one or moretissues are punctured using a slotted sheath. In other variations, themethod comprises visualizing the delivery device. In some of thesevariations, the delivery device is visualized directly. In others ofthese variations, the delivery device is visualized indirectly (e.g.fluoroscopy or ultrasound). In still other variations, the methodscomprise flushing or spraying the paranasal sinus cavity or ostium. Inyet other variations, the methods comprise dilating one or more tissues.

Additionally, the self-expanding device may be released from thedelivery device in any suitable way. In some variations, theself-expanding device may be released from the device by advancing apusher through the cannula. In other variations, the self-expandingdevice may be delivered by withdrawing the cannula relative to a stopperor a sheath. In other variations, the self-expanding device may bereleased by rotating the cannula relative to a stopper or a sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an illustrative depiction of one variation of the devicesdescribed here shown in an expanded configuration. FIG. 1B is a sideview of the device of FIG. 1A shown in its compressed, deliveryconfiguration.

FIGS. 2A-2E depict various loop configurations that may be useful withthe devices described herein.

FIG. 3A is a side view of an illustrative filament that may be usefulwith the devices and methods described here. FIG. 3B is across-sectional view of the filament of FIG. 3A.

FIGS. 4A and 4B depict one variation of how the devices described hereinmay be compressed, using a suture of other suitable material that passesthrough an eyelet of a loop, or other opening of the device.

FIG. 4C demonstrates how the device may be loaded into a deliverydevice.

FIGS. 5A and 5B provide illustrative examples of various deliverydevices that may be useful with the devices and methods described here.FIG. 5C highlights various dimensions associated with the deliverydevices described here.

FIG. 6 is a simplified depiction of the anatomy of the sinuses followinga typical sinus surgery.

FIGS. 7A-7C depict an illustrative method of delivering a device to anethmoid sinus cavity.

FIGS. 8A-8C depict an illustrative method of delivering a device to amaxillary sinus cavity.

FIGS. 9A-9C depict an illustrative method of delivering a device to thevasculature.

FIGS. 10A-10C depict an illustrative method of delivering a device toshunt urine around a blockage.

FIG. 11 is a flow chart outlining one variation of manufacturing thedevices described herein.

FIG. 12 provides the drug release profiles for three different devices.

FIG. 13 depicts in vivo release rate data for three exemplary devicesdescribed here.

FIG. 14 illustrates the cumulative release of mometasone furoate fromtwo different illustrative devices as described here.

FIGS. 15-16 are illustrative depictions of suitable variations ofdevices described here, shown in their expanded configurations.

FIG. 17A is a perspective view of a suitable device, where the devicehas a pattern that approximates a repeating diamond pattern. FIGS. 17Band 17C show side views of other variations of suitable devices havingpatterns similar to the device of FIG. 17A.

FIG. 18 depicts a side view of one variation of a suitable device havinga shape that approximates overlapping crowns.

FIG. 19 is a side view of a suitable device, where the device has apattern that approximates a repeating arrowhead pattern.

FIG. 20 is an illustrative depiction of a suitable device variationshown in its expanded configuration.

FIGS. 21A-21C show an illustrative depiction of a variation in which thedevices comprise slotted tubes. FIGS. 21A and 21C are side views ofthese variations in their unexpanded configurations. FIGS. 21B and 21Dare side views of these variations in their expanded configurations.

FIGS. 22A-22M depict various junction configurations that may be usefulwith the devices described here.

FIGS. 23A and 23B show an illustrative depiction of a steerable cannulathat may be used with the delivery devices described here.

FIGS. 24A-24Q depict various cannula tips that may be useful with thedelivery devices described here.

FIGS. 25A-25G show various illustrative depictions of multi-lumencannulas.

FIGS. 26A and 26B are a side view and a cross-sectional view,respectively, of the distal end of one variation of a delivery devicecomprising a pusher, a cannula, and a sheath.

FIGS. 27-28B depict illustrative variations of delivery devicescomprising pushers.

FIGS. 29A and 29B show one variation of a delivery device comprising astopper.

FIG. 30A is a perspective view of a variation of a delivery devicecomprising a stopper and a cannula. FIGS. 30B and 30C are side views ofthe stopper and cannula, respectively. FIGS. 30D-30F illustrate onemanner of operating the delivery device shown in FIG. 30A.

FIGS. 31A-32B provide illustrative examples the distal ends of variousdelivery devices described here.

FIG. 33 depicts an illustrative example of a delivery device describedhere.

FIG. 34A is a cross-sectional side view of a handle for use with thedelivery devices described here. FIGS. 34B-34D are illustrative examplesof adjustable handles suitable for use with the delivery devicesdescribed here.

FIGS. 35A and 35B depict side views of another variation of a suitabledevice having a shape that approximates overlaid crowns.

DETAILED DESCRIPTION

Described here are self-expanding devices for use within a hollow-bodyorgan, a sinus cavity, the vasculature, or the like. Methods fortreating various conditions or diseases, as well as methods formanufacturing the devices are also described. The devices may haveutility in any area of the body that may benefit from the support orfunction the devices may provide. In some variations, the devices areused in one or more sinus cavities (either before or after a functionalendoscopic sinus surgery). In other variations, the devices are used inthe vasculature, to help improve vessel patency or to provide support orfunctional benefit (for example in areas of plaque or potential plaqueformation, etc.). In still other variations, the devices may be used inthe bladder, ureter, urethra, or the like. Additionally described hereare delivery devices and methods for using the delivery devices. Thedelivery devices may be used to deliver one or more of theself-expanding devices described here, or may be used to deliver one ormore different implants.

I. Devices

Self-Expanding Devices

In general, the devices described here are self-expanding devices,having a first compressed configuration, and a second expandedconfiguration. The devices may or may not be configured to conform to oragainst one or more tissue surfaces in their expanded configuration, andsuch conformation may be facilitated in certain instances by the devicehaving a geometry or configuration that has the ability to conform to anirregular tissue surface or irregular body cavity. Indeed, the devicesmay have any suitable configuration. In some variations, the devicescomprise either a single continuous filament or at least twonon-intersecting filaments. By non-intersecting, it is generally meantthat the filaments do not cross each other in a typical woven fashion.In other variations, the devices comprise two or more separatecomponents, which may be filaments or separate devices, and the separatecomponents may or may not be joined or intersect. The devices may bemade out of any suitable material or materials, and may or may not beconfigured for drug delivery. Typically, at least a portion of thedevices comprises a biodegradable polymer, and the devices areconfigured to degrade over a predetermined period of time. This is notto say that the devices may not be removed if necessary, and in someconfigurations, the devices are configured for easy retrieval and/orremoval.

With specific reference to the figures now, FIGS. 1A and 1B illustrate avariation of device (100) in its expanded and compressed configurations,respectively. In this variation, the device comprises a singlecontinuous filament and is formed into a shape having a series of peaks(102) and valleys (104). While a great many peaks and valleys are shownin the example of FIGS. 1A and 1B, it should be understood that thedevice may comprise any number of peaks or valleys. Additionally, itshould also be understood that while the exemplary device shown in FIGS.1A and 1B have peaks and valleys, the device need not have any peaks orvalleys. Thus, the devices described here may have from zero to a greatmany peaks and valleys.

In the variation shown in FIGS. 1A and 1B, the device also has a seriesof loops (106) formed at the ends of the peaks and valleys. It should beclear that the device need not have such loops, but such loops may bedesirable in certain circumstances. Any number of loops may be formed onthe device, and the loops, as will be described in more detail below,may have any suitable configuration. The loops may be formed on the endsof all the peaks and valleys, some of the peaks and valleys, or none ofthe peaks and valleys. Similarly, the loops may be formed on all or someof the peaks, but none of the valleys, or on all or some of the valleys,but none of the peaks, and the like.

In certain instances, a loop may be desirable as it may help provide foran even distribution of the bending stresses that are applied when thedevice is reduced into its compressed configuration. The ability of theloop to distribute stress may also contribute to the ability of thedevice to self-expand upon deployment by lessening plastic deformationof the device. One or more loops may also serve as sites for drugdelivery, as will be described in greater detail below. In thesevariations, the loops may be coated, or impregnated with a drug, orcoated or impregnated with a polymer for delivery of a drug therefrom.The loops may further be useful in manufacturing of the device, asdescribed below, by for example, serving as an aid for positioning andmanipulating the device.

In some variations, the loops comprise or define eyelets for passage ofa suture therethrough. The suture may be useful, for example, to helpcollapse the device into its compressed configuration when pulled, aswill be detailed below. In other variations the suture (whether passingthrough an eyelet or otherwise attached to the device) may be useful inretrieving the device, either temporarily (in the event of initialmisplacement, for example) or permanently (in the event the device failsto completely degrade or in the event the device needs to be prematurelywithdrawn, e.g., in the event of infection, complication, or the like).The angle (A) defined by the loop apex may be of any suitable degree.For example, the angle may be between about 10° to 170°, between about10° to 150°, between about 10° to 130°, between about 10° to 110°,between about 10° to 90°, between about 10° to 70°, between about 10° to30°, between about 30° to 170°, between about 30° to 150°, between about30° to 130°, between about 30° to 110°, between about 30° to 90°,between about 30° to 70°, between about 30° to 50°, between about 50° to170°, between about 50° to 150°, between about 50° to 130°, betweenabout 50° to 110°, between about 50° to 90°, between about 50° to 70°,between about 60° to 120°, between about 60° to 90°, between about 70°to 170°, between about 70° to 150°, between about 70° to 110°, betweenabout 70° to 90°, between about 90° to 170°, between about 90° to 150°,between about 90° to 130°, between about 90° to 110°, between about 110°to 170°, about 110° to 150°, about 110° to 130°, about 130° to 170°,about 130° to 150°, about 150° to 170°, and the like. In somevariations, the angle is about 75°. It should noted that when the deviceis crimped to a self-expanded device, or placed in a portion of theanatomy, the angle (A) defined by the loop apex may decrease to an anglesmaller than those listed above. Indeed, angle (A) may be reduced to anysuitable angle. For example, the angle may be reduced to an anglebetween about 0° to 30°, about 0° to 25°, about 0° to 20°, about 0° to15°, about 0° to 10°, about 0° to 5°, about 5° to 15°, about 5° to 10°,about 1° to 5°, about 2° to 4°, and the like.

The devices described here are typically capable of self-expanding whendeployed. The rate of expansion may be dependent on a number ofenvironmental factors, for example, temperature, pH, etc., as well ascertain physical characteristics of the device itself, for example, thematerials used and the device configuration. As such, the device may bedesigned to expand at a certain rate under certain conditions. In somevariations, the device, while still self-expandable, may be aided in itsdeployment with use of an expandable balloon, expansion device or aheated element. In some variations, a ball or other structure is pulledthrough the inner diameter of the device in order to aid in the device'sexpansion. In still other variations, the device may be deformable intoits expanded configuration.

Returning back to FIGS. 1A and 1B, device (100) has an expanded diameter(D), shown in FIG. 1A, and a compressed diameter (d), shown in FIG. 1B.The ratio of the expanded diameter (D) to the compressed diameter (d),or D:d, may be representative of how effectively the device may becompressed. This ratio may be any suitable ratio. For example, the ratiomay be from about 2:1 to about 20:1, from about 2:1 to about 15:1, fromabout 2:1 to about 12:1, from about 2:1 to about 8:1, from about 2:1 toabout 5:1, from about 5:1 to about 20:1, from about 5:1 to about 15:1,from about 5:1 to about 12:1, from about 5:1 to about 8:1, from about5:1 to about 8:1, from about 8:1 to about 20:1, from about 8:1 to about15:1, from about 8:1 to about 12:1, from about 12:1 to about 20:1, fromabout 12:1 to about 15:1, from about 15:1 to about 20:1, about 10:1, andthe like. The actual values of the expanded and compressed diameterswill typically depend on the target site for deployment, so thatappropriate tissue apposition may be effected. However, in general, thecompressed configuration has a diameter suitable for low profiledelivery using a delivery device. For example, the diameter (d) of thedevice in the compressed configuration may be from about 0.05 mm toabout 5.5 mm, from about 0.05 mm to about 3 mm, from about 0.05 mm toabout 1 mm, from about 1 mm to about 5.5 mm, from about 1 mm to about 3mm, from about 3 mm to about 5.5 mm, and the like. In some variations,the diameter (d) of the device in its compressed configuration is about4.5 mm. It should also be understood that while the device may providesupport for a given area, the device need only be in physical contactwith a fraction of that area, for example, about 5% of that area.

It should be understood that while shown as having a generally crownshape in FIGS. 1A and 1B, the device may be any shape capable ofassuming an expanded configuration for apposition against tissue, aswell as a compressed configuration for low profile delivery. Forexample, the device may have a generally double crown type shape, mayhave a generally smooth, undulating type shape, may have a generallyhelical type shape, or the like.

FIG. 15 illustrates one variation of a suitable device (1500) in itsexpanded configuration. This variation may find particular utility ininstances where it is desirable to provide differing amounts of supportto different areas of surrounding tissue. In this variation, the devicecomprises a single continuous filament formed into a shape having aseries of valleys (1502), a series of lower peaks (1504), and a seriesof upper peaks (1506), which combine to form a device having a generallyvarying crown shape. While many upper peaks, lower peaks, and valleysare shown in FIG. 15, the device may include any number of peaks orvalleys. When device (1500) is in its expanded configuration, each upperpeak (1506) will have an upper peak height (H) relative to the valleys(1502), and each lower peak (1504) will have a lower peak height (h)relative to the valleys (1502). The upper (H) and lower (h) peak heightsmay be any suitable values, and these values may be selected ordetermined based on the intended manner in which the device will beused.

While the peaks of device (1500) shown in FIG. 15 alternate betweenupper peaks (1506) and lower peaks (1504), they may take on any suitablearrangement or pattern. In some variations, this arrangement may followa repeating pattern, but need not. Furthermore, in some variations thenumber of upper peaks (1506) may be equal to the number of lower peaks(1504). Of course, in other variations, the number of upper peaks (1506)is not equal to the number of lower peaks (1504). Indeed, all but one ofthe peaks may be an upper peak (1506), all but one of the peaks may be alower peak (1504), or the peaks may comprise some mixture of upper(1506) and lower (1502) peaks. Additionally, the device (1500) may havea series of loops (1508) formed at the ends of the upper peaks, lowerpeaks, and valleys, but need not. The loops, which were describedbriefly above and will be described in more detail below, may be formedon all, some, or none of the upper peaks, on all, some, or none of thelower peaks, or on all, some, or none of the valleys, or somecombination thereof.

While shown in FIG. 15 as having two distinct series of peaks (upper(1506) and lower (1504)), the device (1500) may alternatively have threeor more distinct series of peaks. Each series of peaks may have anynumber of that type of peak, and the peaks of each series may have anyheight relative to the valleys. Furthermore, the series of peaks mayhave any suitable arrangement or pattern as described above.

FIG. 16 shows another variation of a suitable device (1600) in itsexpanded configuration. In this variation, the device (1600) comprises asingle continuous filament and is formed into a shape having series ofupper valleys (1602), lower valleys (1604), upper peaks (1606) and lowerpeaks (1608). As with all devices described above and throughout, thedevice of this variation may have any number of peaks or valleys, andthe peaks (upper or lower) may have any suitable height relative to thevalleys (upper or lower). The peaks and valleys may take on anyarrangement or pattern as described above in relation to theillustrative example of FIG. 15. For example, in the variation shown inFIG. 16, the upper peaks (1606) alternate with the lower peaks (1608),and the upper valleys (1602) alternate with the lower valleys (1604) tocreate a device having a generally quasi-crown shape. Additionally, thedevice (1600) may have a series of loops (1610) formed at the ends ofthe upper peaks, lower peaks, upper valleys, lower valleys, or somecombination thereof. Of course, the device need not have any loops.Additionally, it should be understood that the loops (describedhereinthroughout) may be formed on all, some, or none of the upperpeaks, on all, some, or none of the lower peaks, on all, some, or noneof the lower valleys, or on all, some, or none of the upper valleys, orsome combination thereof.

The type of device chosen (i.e., length, geometry, number of loops,etc.) may be selected based on the particular use of the device. In someinstances it may be desirable to select a device having a longer lengththan the devices described just above, yet having sufficient radialstrength to overcome forces applied to it during use. FIG. 17Aillustrates one variation of device (1700) having a length longer thanthose described above, here shown in its expanded configuration. In thisvariation, the device comprises one or more filaments and is formed intoa shape having a series of peaks (1702), valleys (1704), and junctions(1706). While many peaks, valleys, and junctions are shown in FIG. 17A,the device (1700) may include any suitable number of each of theseelements. Furthermore, although the junctions (1706) in the illustrativedevice depicted in FIG. 17A are located between peaks (1702) and valleys(1704) to create a substantially diamond-shaped pattern, it should beappreciated that the device may take on any pattern. Indeed, in somevariations the device may take on a substantially kite-shaped pattern,or the like.

Additionally, the device (1700) may have a series of loops (1708) at thepeaks, valleys, junctions, or some combination thereof. It should benoted that the device need not have such loops, but loops may bedesirable in certain circumstances as described hereinthroughout.Furthermore, any number of loops may be formed on the device, and eachloop may have any suitable configuration as described below. Forexample, the loops may be formed on all, some, or none of the peaks,valleys, junctions, or combination thereof.

The overall structure of the device depicted in FIG. 17A may be achievedin any number of different ways. In some variations (not shown),separate filaments are joined together to form substantially diamondshapes. In others variations, as shown in FIG. 17B, the structure ofdevice (1710) may be achieved by positioning a top crown-shaped device(1712), such as the exemplary device shown in FIG. 1A, above a bottomcrown-shaped device (1714). In this way, a modular or composite deviceis formed. Of course the device may comprise any number of modular orseparate units, to create a device having any suitable length orgeometry.

In these variations, each of the top (1712) and bottom (1714)crown-shaped devices has a series of peaks (1716) and valleys (1718). Assuch, the peaks of the top crown-shaped device (1712) form the peaks ofdevice (1710) while the valleys of the bottom crown-shaped portion(1714) form the valleys of device (1710). The valleys of the topcrown-shaped device (1712) join with the peaks of the bottom device(1714) to form junctions (1720). In some variations, the top (1712) andbottom (1714) crown-shaped portions may have different axial lengths,and thus may have different radial strengths. While modular or compositedevices are described with respect to this variation, it of courseshould be understood that these types of devices may also be formed froma single continuous filament.

In still other variations, as shown in FIG. 17C, device (1722) may beformed by positioning first crown-shaped device (1724), such as theexemplary device shown in FIG. 1A, in a phase-shifted position relativeto second crown-shaped device (1726). Both first (1724) and second(1726) crown-shaped devices have series of peaks (1728) and valleys(1730), which constitute the peaks and valleys of the device (1722).Additionally, junctions (1732) are formed by the intersection of thefilaments of the two crown-shaped devices. The device (1722) may beformed from a single continuous filament, or may be formed from acombination of two separate devices. Of course, when the device ismodular in nature, each individual device may be formed from a singlecontinuous filament or from more than one filament.

While the crown-shaped devices shown in FIG. 17C are positioned suchthat the peaks of one crown-shaped device are positioned above thevalleys of the other crown-shaped device, the crown-shaped devices mayhave any relative positioning. Depending on the relative rotation (orphase shift) between the first (1724) and second (1726) crown-shapeddevices, the device (1724) may cease to have the overall structure showngenerally in FIGS. 17A-17C, instead taking on a rectangular-shaped, orother shaped pattern (not shown). If the phase shift between the twodevices is of a large enough magnitude, as illustrated in FIG. 18,device (1800) is formed such that the peaks (1806) of the first (1802)and second (1804) crown-shaped devices are positioned substantially inalignment. In this variation, the valleys (1808) of the first (1802) andsecond (1804) crown-shaped devices are also positioned substantially inalignment. Although junctions (1810) may be positioned approximatelyequidistant between the peaks and valleys, of the first crown-shapeddevice (1802), as shown in FIG. 18, the first (1802) and second (1804)crown-shaped devices may alternatively be shifted axially relative toeach other. For example, in some variations (not shown), the first andsecond crown-shaped devices are axially oriented such that the peaks ofeach crown-shaped device join to form junctions. In other variations,the valleys of each crown-shaped device may join to form junctions.

FIGS. 35A and 35B illustrate another modular variation of device (3500)comprising first (3502) and second (3504) crown-shaped devices. FIG. 35Bshows first (3502) and second (3504) crown-shaped devices separated,while FIG. 35A shows first (3502) and second (3504) crown-shape devicesconnected at junctions (3506) to form device (3500). As shown in FIG.35B, junctions (3506) may be formed by connecting filaments (3508) fromeach crown-shaped device such that the filaments (3508) do not overlap.These junctions (3506) may be formed in any suitable manner (e.g,bonding, welding, mechanical fastening). When the device (3500) iscrimped, filaments (3508) in junction (3506) may rotate in the samedirection, as opposed to rotating in different directions, which may inturn help prevent the filaments (3508) from disengaging. This may, inturn, increase the overall strength of device (3500). It should benoted, however, that each junction of device (3500) may be any suitablejunction as described in more detail below.

In still other variations, as shown in FIG. 19, device (1900) comprisesfirst (1902), second (1904) and third (1904) crown-shaped devices, witheach crown-shaped device having a series of peaks (1907) and valleys(1908). Device (1900) may be made from a single continuous filament, ormay be made from individual crown-shaped devices in a composite fashion(e.g., where each crown-shaped device is made from a separate continuousfilament). In some variations, the first (1902) and second (1904)crown-shaped devices are oriented such that the peaks of each devicejoin to form upper junctions (1910). In some of these variations, thefirst (1902) and third (1906) crown-shaped devices are axially orientedsuch that the valleys of each device join to form lower junctions(1912). In these variations, the overall structure of device (1900)takes on a generally repeating arrowhead-shaped pattern. It should beappreciated that the overall structure of these devices may be changedeither by phase-shifting one or more of the crown-shaped devices inrelation to the entire device, by axially shifting one or more of thecrown-shaped devices in relation to the entire device, some combinationof the foregoing, and the like.

FIG. 20 shows yet another variation of device (2000) in its expandedconfiguration. Shown there are first (2002) and second (2004)quasi-crown-shaped devices, such as the device illustrated in FIG. 16.In these variations, the first (2002) and second (2004)quasi-crown-shaped devices have upper (2006) and lower (2008) peaks,upper (2010) and lower (2012) valleys, and junctions (2014). In somevariations, one of the quasi-crown-shaped devices may be phase-shiftedrelative to the other, axially shifted relative to the other,combinations thereof, and the like. In other variations (not shown), oneor more of the quasi-crown-shaped devices may be replaced by one or morevarying-crown-shaped devices. In still other variations, one or more ofthe quasi-crown-shaped devices may be replaced with a crown-shapeddevice as described above. Additionally, some variations may containmore than two devices that are quasi-crown-shaped, crown-shaped,varying-crown-shaped, some combination thereof, and the like.

The entire device (2000) may be made of one continuous filament, or maybe modular or composite in nature. The device may additionally contain aseries of loops (2016), but need not. These loops may take on anysuitable configuration as described below. The loops may be formed on ofall of the peaks, valleys, and junctions, some of the peaks, valleys andjunctions, none of the peaks, valleys, and junctions, or somecombination thereof. The junctions may take on any suitableconfiguration as described below.

When loops are used with the devices described herein, they may have anysuitable configuration. FIGS. 2A-2E provide a number of illustrativeexamples of suitable loop configurations for use with any of thedescribed devices. Shown in FIG. 2A is a variation of loop (200)including drug depot (202). In this variation, device filament (204) hasbeen curled more than about 360°, but less than about 720° to create afull loop. FIG. 2B illustrates a variation of loop (206), in which thedevice filament (208) has been curled less than about 360°. Shown inFIG. 2C is a variation of loop (210) in which the device filament (212)has been curled more than about 720° to create two loops. FIG. 2Ddepicts a loop (214) in which the device filament (216) has been curledin several full rotations in order to create a spring-likeconfiguration. FIG. 2E depicts a loop (218) in which the device filament(220) has been rotated less than 360° in one direction to form a firstloop, then rotated approximately 360° in the opposite direction to forma second loop, the two loops thus approximating the shape of a figureeight. Of course, these are just a few of the many types of loopconfigurations that may be used.

Although a drug depot (202) is shown only FIG. 2A, drug depots or drugdelivery sites may be used in conjunction with any loop configurationwhen drug delivery is desirable. As described above, some, all or noneof the loops of a device may contain a drug depot or drug delivery site.Additionally, drug depots may be contained on or in any portion of thedevices. In some variations, the drug depot is in the form a polymercoating, and made similar to the polymeric drug eluting layers describedhereinthroughout. In other variations, the drug depot (202) may come inthe form of a drop or bead of drug-filled material placed within, on, oraround an outer area of the loop. When the device comprises a filamentthat has perforations, such as slots, holes or channels, the drug depotmay also (or alternatively) be contained therein. When more than onedrug depot is used, the drugs for delivery therefrom may be the same ordifferent. Similarly, drug released from a drug depot may be the same ordifferent from a drug released from other portions of the device. Thedrug depot may release drug at the same rate as the rest of the device,or may release drug at a different rate.

While some junctions comprise one or more loops as will be describedbelow, it is noted that junctions are generally differentiated fromloops in that junctions occur at the intersection or meeting of two ormore filaments or filament sections. When junctions are used with thedevices described here, they may have any suitable configuration. Theconfiguration of a given junction may be the same as or different fromother junctions within the same device. FIGS. 22A-22M provideillustrative examples of suitable junction configurations. Shown in FIG.22A is one variation of junction (2200), including two straightfilaments (2202) and suture ties (2204). While shown in FIG. 22A asincluding suture ties (2204), junction (2200) need not. Indeed, in somejunctions the two filaments are not bound, joined, or attached in anyway. In other variations, one or more elastic bands, washer rings,gaskets, clamps, sutures, clips, other mechanical fasteners, or acombination thereof may be used to join the two filaments. In stillother variations, the two filaments may be joined using welding (e.g.,heat welding, ultrasonic welding, tacking, staking, and the like), maybe bonded using glue, adhesives, or low melting temperature polymers, orthe like. In variations that utilize a polymer, the polymer may bebiodegradable. Additionally the polymer may be configured to release oneor more drugs over a period of time. In still other variations, asillustrated in FIG. 22B, junction (2206) includes bolt or otherbiocompatible, (and in some variations biodegradable) cylinder (2210)that is placed through holes or channels (not shown) formed in thefilaments. (2208). In this way, the bolt (2210) may help allow forrotation between the filaments (2208), but not transverse movementtherebetween. While shown in FIG. 22B as having a bolt (2210), thejunction (2206) may include any suitable rod, screw, pin, peg, orcylinder (in most cases made from a biocompatible and biodegradablematerial). It should also be appreciated that any appropriatecombination of processes and structures for joining or bonding two ormore filaments, as described above, may be used in these junctions.

FIG. 22C shows another variation of junction (2212) in which filaments(2214) are bent around each other. The filaments (2214) may additionallybe bound using any combination of processes and structures describedabove. While shown in FIG. 22C as being bent at approximately 90°angles, the filaments (2214) may be bent at any suitable angles. Inother variations, as shown in FIG. 22D, junction (2216) may be formed bywinding filaments (2218) around each other to form a generally helicalstructure. The helices of these variations may include any number ofturns or loops. Also, while the wound filaments (2218) are configuredvertically, they may alternatively be configured horizontally, as shownin FIG. 22E, or at an angle (not shown).

In some variations, one or more of the filaments form a loop at thejunction. In these variations, the loops may have any configuration asdescribed above. In variations in which more than one fiber form loops,these loops may have the same or different configurations. FIG. 22Fshows one variation of junction (2220) including filaments (2222) andloop (2224). In this variation, one filament passes straight through theloop created by the other filament. In other variations, such asjunction (2226) shown in FIG. 22G, a filament (2228) is passed throughthe loop (2230) at an angle or in a bent manner. These junctions can beformed by either winding a first filament around a second filament, orby threading a first filament through a pre-formed loop.

In other variations, the junction comprises at least two loops formedfrom at least two fibers. FIG. 22H shows one such variation of junction(2232), including filaments (2234), loops (2236), and suture tie (2238).In the illustrative example shown in FIG. 22H, the two loops (2236) arebound to each other using a suture tie (2238). However, it should beappreciated that any combination of structures or processes as describedabove may be used to join the loops. Additionally, in some variations,one loop has a certain orientation relative to another. For example,FIGS. 22I and 22J show a side and front view respectively of onevariation of junction (2242). Shown there are loops (2240) which arejoined using barbell-shaped structure (2244) such that the loopapertures (not shown) are in alignment. The barbell-shaped structure(2244) generally allows the loops (2240) to rotate with respect to eachother, but not to move laterally with respect to each other. In somevariations (not shown), the barbell-shaped structure has a channel intowhich a drug depot may be placed, or through which a suture may bepassed. While shown in FIGS. 22I and 22J as having a barbell-shapedstructure (2244), and suitable structure may be used. For example, ascrew may be threaded through the apertures defined by the loops.

FIG. 22K shows another variation of junction (2246) including filaments(2248) and loops (2250). For each loop, the filament creating that loopis wound through the aperture (2252) defined by the other loop. In somevariations, this allows for relative rotation between the loops. Thisjunction (2246) may be formed by winding a filament around a pre-formedloop, or by simultaneously winding two filaments. It should also beappreciated that the loops may be further bound or joined using any ofthe processes or structures as described above.

In other variations, such as that shown in FIG. 22L, junction (2254)comprises outer loop (2256) which is wound around the exterior of innerloop (2258). The apertures defined by the two loops may be concentric.In some of these variations, a drug depot may be placed within theaperture defined by the inner loop (2258) or a suture may be threadedtherethrough. In some of these variations, the inner loop (2258) may beable to rotate relative to the outer loop (2256). FIG. 22M shows stillanother variation of junction (2260), comprising loops (2262) that arehelically wound. The aperture (2264) defined by the helically woundloops (2262) may hold one or more drug depots therein, or may have asuture passed therethrough. It should also be appreciated that thejunctions of these variations may be further bound using any combinationof the structures and process described above. Of course, the variationsdescribed here are just a few of the many types of junctionconfigurations that may be used with the devices described herein.

In many variations of the devices described here, the devices are formedfrom one or more individual filaments, however the devices need not beformed in such fashion. For example, FIGS. 21A and 21B show a variationof a suitable device (2100) in its unexpanded and expandedconfigurations, respectively. In this variation, the device (2100)comprises a slotted tube (2102). The tube may in turn comprise a seriesof alternating slots (2104) and struts (2106). While a great many slots(2104) and struts (2106) are shown in FIGS. 21A and 21B, any suitablenumber of slots and struts may be included. When device (2100) is in itsunexpanded configuration, the struts (2106) lay substantially in linewith tube (2102). When device (2100) is in its expanded configuration,the struts (2106) bend, flex, or deform away from the body of tube(2102). This expansion decreases the length of tube (2102) whileincreasing the radius of portions of tube (2102). While shown in FIGS.21A and 21B as having one set of alternating slots (2104) and struts(2106), the device may have any number of sets of slots and struts. Forexample, as shown in FIGS. 21C and 21D in its unexpanded and expandedconfigurations respectively, device (2108) has two sets of alternatingslots (2110) and struts (2112) located within tube (2114). While shownin FIGS. 21A-21D as being approximately rectangular in shape, the slotsand tubes may take on any suitable shapes or configurations. Of course,the struts (2112) themselves may be made from one or more filaments asdescribed herein.

FIGS. 3A and 3B provide illustrative depictions of a suitable filamentfor use with any of the devices described here. FIG. 3A depicts a sideview of a filament, and FIG. 3B depicts a cross-sectional view of thefilament of FIG. 3A. Shown in these figures is filament (302) and drugeluting layer (304). Filament (302) may be made from any suitablebiocompatible material. Typically, this filament (302) comprises abiodegradable polymer that is capable of degrading over a predeterminedperiod of time. The polymer may be semi-crystalline, crystalline, oramorphous in nature. Suitable polymers for use with the devices will bedescribed in detail below.

Although depicted in FIGS. 3A and 3B as being completely solid, thefilament (302) may include features that promote flow of mucous or otherbodily fluids around them (e.g., one or more porous beads, or the like).The filament (302) may also include features that increase the surfacearea upon which drug eluting layer (304) may be deposited. In somevariations, the filament (302) may be formed as a perforated structure,including holes, slots, channels or the like. It should be understoodthat while the filament depicted in FIGS. 3A and 3B include a drugeluting layer (304), the devices described here need not have such alayer. It should also be understood that while the drug eluting layer(304) is shown as generally continuous in nature, in need not be.Indeed, the layer may be discontinuous, covering only a portion, orselected portions of the polymer filament. Similarly, while the filamentis shown in FIG. 3A as having a generally cylindrical cross-section, thecross-section may be of any suitable geometry. Also, while the drugeluting layer (304) is shown as having a greater thickness than thefilament (302) it surrounds, it should be understood that the respectivethicknesses of these components may be selected based upon the final useof the device. These figures are merely illustrative and any number ofadditional configurations may be used as desirable.

While shown in FIG. 3B as comprising a polymer (306) containing drugparticles (308) therein, drug eluting layer (304) may be made of anysuitable biocompatible material that is capable of releasing a drug overa period of time, and may be configured in any suitable way. This drugdelivery period may vary as desirable, and the drug eluting layer (304)may, accordingly be configured to release drug over a predeterminedperiod of time. In some variations, this period of time is configured tobe as long as is required for the filament (302) to biodegrade. In othervariations, this period of time may be on the order of hours, on theorder of days, on the order of weeks, or on the order of months. Theperiod of drug delivery will likely be determined with consideration ofthe use of the device. For example, when the device is used for treatingone or more conditions of the sinuses, the period may be between about 1day to about 10 days, between about 1 to about 8 days, between about 1to about 5 days, between about 1 to about 3 days, between about 5 toabout 120 days, between about 5 to about 90 days, between about 5 toabout 60 days, between about 5 to about 45 days, between about 5 toabout 20 days, between about 2° to about 90 days, between about 2° toabout 60 days, between about 2° to about 45 days, between about 45 toabout 90 days, between about 45 to about 60 days, between about 45 toabout 90 days, between about 45 to about 60 days, or about 30 days. Insome variations, as described below, the rate of drug delivery may notbe constant over the period of time.

As described above, the drug eluting layer may comprise a polymer(although need not). In some variations, the drug eluting comprises abiodegradable polymer, e.g., poly(DL-lactide-co-glycolide) (i.e., PLG),poly(lactide), poly(glycolide), trimethylated chitosan, or any of thebiodegradable polymers described below. In variations using PLG, anysuitable molar ratio of lactide to glycolide may be used. For example,the molar percent of lactide or the molar percent of glycolide may beany suitable amount, for example, between about 0% and about 100%,between about 30% and about 100%, between about 50% and about 100%,between about 70% and about 100%, between about 0% and about 70%,between about 30% and about 70%, between about 50% and about 70%,between about 0% and about 50%, between about 30% and about 50%, betweenabout 0% and about 50% and the like. In some variations, the molar ratioof lactide to glycolide is about 70:30.

In a similar manner, the filament (302) may comprise a polymer, forexample, a biodegradable polymer e.g., PLG, poly(lactide),poly(glycolide), or any of the biodegradable polymers described below.In variations using PLG, any suitable molar ratio of lactide toglycolide may be used. For example, the molar percent of lactide or themolar percent of glycolide may be between about 70% and 100%. In somevariations, the molar ratio of lactide to glycolide is about 10:90. Inother variations, the filament does not comprise a polymer, but is stillcapable of degrading over a period of time. For example, the filamentmay comprise polytyrosine carbonate, tephaflex, hyaluronic acid,collagen, mixtures thereof, or the like.

The filament may additionally include one or more metallic regions. Thismay be desirable, for example, to help control the rate of degradationof the device, to provide radio-opacity to the device, to increase themechanical integrity of the device, or the like. In some variations, themetallic region may include struts with a cylindrical or substantiallycylindrical cross-section. Alternatively, the struts may have square,rectangular, oval, or other cross-sectional shapes. In other variations,the metallic region may include metallic particles that are mixedthroughout a portion of the filament material. The metallic region maybe capable of degrading when exposed to bodily fluids, and may besurrounded by any suitable polymer or other material. The metallicregion may also have one or more pores that are configured to includedrug particles. Examples of suitable metallic materials include, but arenot limited to zinc, magnesium, and iron.

In variations that include a metallic region, the device filament may beconfigured to degrade more slowly than the metallic region when exposedto bodily fluids. In some of these variations, the filament may beconfigured to delay, inhibit, or prevent degradation of the metallicregion in a manner that allows the metallic region to provide additionalmechanical support to the device filament over a selected period oftime. This may occur by the filament shielding the metallic region frombodily fluids over a selected time period. A metallic region may startto degrade when the filament material is only partially degraded or maystart to degrade when the filament material is completely degraded. Insome variations, the metallic region may be configured to completely oralmost completely degrade before the filament material completelydegrades. In other variations, the filament material may be configuredto completely or almost completely degrade before the metallic regioncompletely degrades.

The devices may also comprise one or more flexible sections. Theflexible sections may be selectively positioned to inhibit or preventfracturing in the device when subjected to applied stresses during use.For example, the flexible sections may be placed within or near loops,in device variations having them. This may be helpful because stressesapplied during use such as crimping, delivery, deployment, and the like,may cause deformation or strain in the structural elements of a deviceand may be greater in elements that are configured to bend (such as theloops). In some variations, the flexible section comprises a regionhaving a cavity formed within the device including, but not limited to,a loop. Such a cavity may be formed by laser cutting, and may or may notbe filled with a polymer or a polymer-solvent mixture.

When used, the flexible section(s) may have any suitable cross-sectionalshape, including but not limited to, rectangular, circular, and oval. Insome variations, the cross-section of the flexible section can varythrough the thickness of the device. For example, the width of theflexible section along the length of a loop may be directly proportionalto the magnitude of the strain along the loop when the device is understress. In these variations, a flexible section may be widest at orproximate to the center of a bending portion of the loop and decrease ineither direction along a length of the loop. Any number of flexiblesections may be used, and in some variations, an individual loop mayhave two or more flexible sections. Multiple cavities may allow forreduction in strain in a high strain region without reducing thestructural integrity of the device.

In device variations in which the filament comprises one or morepolymers, the device may additionally contain one or more plasticizingagents. Plasticizing agents, may for example, be useful in increasingthe total strain that can be experienced by a device filament before itfails (e.g., when the device no longer properly holds open and, ifdesired, expands a passageway or cavity, or when the device cracksand/or breaks in a high-strain regions). Cracks may be caused bycrimping of the device prior to delivery, or by deployment of thedevice, and a plasticizing agent may help prevent the formation of suchcracks. The plasticizing agent may leach out of the device afterdeployment at a target location, thus potentially aiding in the devicerigidity, and potentially, mechanical integrity. The leaching of theplasticizing agent may be timed. For example, it may be timed to leachout as stress is placed on the device, thus potentially addingmechanical integrity when it needs it most.

It should be understood that the terms “plasticizer” and “plasticizingagent” are used interchangeably herein throughout. A plasticizing agentmay include any agent or combination of agents that can be added tomodify the mechanical properties of a polymeric composition or a productformed from a polymeric composition. In some variations, theplasticizing agent can be combined with a water-containing solvent or alipid-containing solvent at temperatures that range from about roomtemperature to about body temperature to form a liquid or semi-solid. Inother variations, the plasticizing agents can dissolve in a limitedamount of water and leach from a polymeric material. In othervariations, the plasticizing agent can dissolve in a bodily fluid.

Without intending to be bound by any theory or mechanism of action, itis thought that plasticizers may help reduce crystallinity, lower theglass-transition temperature (T_(g)), or reduce the intermolecularforces between polymers, creating or enhancing a flow between polymersin the composition. The mechanical properties that may be modifiedinclude, but are not limited to, Young's modulus, tensile strength,impact strength, tear strength, and strain-to-failure. The plasticizercan be monomeric, polymeric, co-polymeric, or a combination thereof, andcan be added to a polymeric composition with or without covalentbonding.

Examples of classes of plasticizing agents include, but are not limitedto, low molecular weight polymers such as, for example, single-blockpolymers, multi-block polymers, and copolymers; oligomers such as, forexample, lactic acid oligomers including, but not limited to,ethyl-terminated oligomers of lactic acid; dimers of cyclic lactic acidand glycolic acid; small organic molecules; hydrogen bond formingorganic compounds with and without hydroxyl groups; polyols such as lowmolecular weight polyols having aliphatic hydroxyls; alkanols such asbutanols, pentanols and hexanols; sugar alcohols and anhydrides of sugaralcohols; polyethers such as poly(alkylene glycols); esters such ascitrates, phthalates, sebacates and adipates; polyesters; aliphaticacids; saturated and unsaturated fatty acids; fatty alcohols;cholesterol; steroids; phospholipids such as, for example, lecithin;proteins such as animal proteins and vegetable proteins; oils such as,for example, the vegetable oils and animal oils; silicones; acetylatedmonoglycerides; diglycerides; triglycerides; amides; acetamides;sulfoxides; sulfones; pyrrolidones; oxa acids; diglycolic acids; and anyanalogs, derivatives, copolymers and combinations thereof.

In some variations, the plasticizers include, but are not limited topolyols such as, for example, caprolactone diol, caprolactone triol,sorbitol, erythritol, glucidol, mannitol, sorbitol, sucrose, andtrimethylol propane. In other variations, the plasticizers include, butare not limited to, glycols such as, for example, ethylene glycol,diethylene glycol, triethylene glycol, tetraethylene glycol, propyleneglycol, butylene glycol, 1,2-butylene glycol, 2,3-butylene glycol,styrene glycol, pentamethylene glycol, hexamethylene glycol;glycol-ethers such as, for example, monopropylene glycol monoisopropylether, propylene glycol monoethyl ether, ethylene glycol monoethylether, and diethylene glycol monoethyl ether; and any analogs,derivatives, copolymers and combinations thereof.

In still other variations, the plasticizers include, but are not limitedto esters such as glycol esters such as, for example, diethylene glycoldibenzoate, dipropylene glycol dibenzoate, triethylene glycolcaprate-caprylate; monostearates such as, for example, glycerolmonostearate; citrate esters; organic acid esters; aromatic carboxylicesters; aliphatic dicarboxylic esters; fatty acid esters such as, forexample, stearic, oleic, myristic, palmitic, and sebacic acid esters;triacetin; poly(esters) such as, for example, phthalate polyesters,adipate polyesters, glutate polyesters, phthalates such as, for example,dialkyl phthalates, dimethyl phthalate, diethyl phthalate, isopropylphthalate, dibutyl phthalate, dihexyl phthalate, dioctyl phthalate,diisononyl phthalate, and diisodecyl phthalate; sebacates such as, forexample, alkyl sebacates, dimethyl sebacate, dibutyl sebacate;hydroxyl-esters such as, for example, lactate, alkyl lactates, ethyllactate, butyl lactate, allyl glycolate, ethyl glycolate, and glycerolmonostearate; citrates such as, for example, alkyl acetyl citrates,triethyl acetyl citrate, tributyl acetyl citrate, trihexyl acetylcitrate, alkyl citrates, triethyl citrate, and tributyl citrate; estersof castor oil such as, for example, methyl ricinolate; aromaticcarboxylic esters such as, for example, trimellitic esters, benzoicesters, and terephthalic esters; aliphatic dicarboxylic esters such as,for example, dialkyl adipates, alkyl allylether diester adipates,dibutoxyethoxyethyl adipate, diisobutyl adipate, sebacic esters, azelaicesters, citric esters, and tartaric esters; and fatty acid esters suchas, for example, glycerol, mono- di- or triacetate, and sodium diethylsulfosuccinate; and any analogs, derivatives, copolymers andcombinations thereof.

In other variations, the plasticizers include, but are not limited toethers and polyethers such as, for example, poly(alkylene glycols) suchas poly(ethylene glycols) (PEG), poly(propylene glycols), andpoly(ethylene/propylene glycols); PEG derivatives such as, for example,methoxy poly(ethylene glycol) (mPEG); and ester-ethers such as, forexample, diethylene glycol dibenzoate, dipropylene glycol dibenzoate,and triethylene glycol caprate-caprylate; and any analogs, derivatives,copolymers and combinations thereof.

In other variations, the plasticizers include, but are not limited to,amides such as, for example, oleic amide, erucic amide, and palmiticamide; alkyl acetamides such as, for example, dimethyl acetamide;sulfoxides such as for example, dimethyl sulfoxide; pyrrolidones suchas, for example, n-methylpyrrolidone; sulfones such as, for example,tetramethylene sulfone; acids such as, for example, oxa monoacids, oxadiacids such as 3,6,9-trioxaundecanedioic acid, polyoxa diacids, ethylester of acetylated citric acid, butyl ester of acetylated citric acid,capryl ester of acetylated citric acid, and diglycolic acids such asdimethylol propionic acid; and any analogs, derivatives, copolymers andcombinations thereof.

In other variations, the plasticizers include, but are not limited tovegetable oils including, but not limited to, epoxidized soybean oil;linseed oil; castor oil; coconut oil; fractionated coconut oil;epoxidized tallates; and esters of fatty acids such as stearic, oleic,myristic, palmitic, and sebacic acid; essential oils including, but notlimited to, angelica oil, anise oil, arnica oil, aurantii aetheroleum,valerian oil, basilici aetheroleum, bergamot oil, savory oil, buccoaetheroleum, camphor, cardamomi aetheroleum, cassia oil, chenopodiumoil, chrysanthemum oil, cinae aetheroleum, citronella oil, lemon oil,citrus oil, costus oil, curcuma oil, carlina oil, elemi oil, tarragonoil, eucalyptus oil, fennel oil, pine needle oil, pine oil, filicis,aetheroleum, galbanum oil, gaultheriae aetheroleum, geranium oil, guaiacwood oil, hazelwort oil, iris oil, hypericum oil, calamus oil, camomileoil, fir needle oil, garlic oil, coriander oil, carraway oil, lauriaetheroleum, lavender oil, lemon grass oil, lovage oil, bay oil, lupulistrobuli aetheroleum, mace oil, marjoram oil, mandarine oil, melissaoil, menthol, millefolii aetheroleum, mint oil, clary oil, nutmeg oil,spikenard oil, clove oil, neroli oil, niaouli, olibanum oil, ononidisaetheroleum, opopranax oil, orange oil, oregano oil, orthosiphon oil,patchouli oil, parsley oil, petit-grain oil, peppermint oil, tansy oil,rosewood oil, rose oil, rosemary oil, rue oil, sabinae aetheroleum,saffron oil, sage oil, sandalwood oil, sassafras oil, celery oil,mustard oil, serphylli aetheroleum, immortelle oil, fir oil, teatreeoil, terpentine oil, thyme oil, juniper oil, frankincense oil, hyssopoil, cedar wood oil, cinnamon oil, and cypress oil; and other oils suchas, for example, fish oil; and, any analogs, derivatives, copolymers andcombinations thereof.

It should be appreciated that, in some variations, one of skill in theart may select one or more particular plasticizing agents in order toexclude any one or any combination of the above-described plasticizingagents. In some variations, the plasticizing agent can include acomponent that is water-soluble. In other variations, the plasticizingagent can be modified to be water-soluble. In some variations, theplasticizing agent can include a component that is lipid-soluble. Inother variations, the plasticizing agent can be modified to belipid-soluble. Any functional group can be added to modify theplasticizer's behavior in a solvent such as, for example, body fluidsthat are present in vivo. Any other suitable functional group may beused.

In some variations, the device contains one or more movable pieces, orone or more locking or interlocking pieces. For example, interlockingpieces may be desirable to help minimize inadvertent collapse of thedevice in use, from its expanded configuration, back to its compressedconfiguration, or to some fraction of its expanded configuration havingless utility. Any number of locking or interlocking pieces may be used.For example, the device may be made completely from interlocking pieces,and these interlocking pieces may be fabricated from a single unitarymaterial. The interlocking pieces may be made to operate in any suitablemanner. In some variations, the interlocking pieces slide and lock intoplace, such as those pieces described in U.S. Pat. Nos. 6,033,436,6,224,626, and 6,951,053, the disclosures of such features, are hereinincorporated by reference in their entirety.

In variations in which the device has a crown shape, quasi-crown shape,diamond shape, or any of the other shapes described above, locking orinterlocking pieces may be placed at locations between the peaks and thevalleys (although they may indeed be placed at any suitable location orlocations along the device). These pieces may be formed during devicemanufacture, or may be later attached to the device (e.g., when thedevice is in its compressed configuration). When the device is expanded,the locking pieces engage, preventing inadvertent, undesirable, orpremature collapse of the device.

Illustrative Polymers

As described above, one or more components of the device may be madefrom a biodegradable polymer. The rate of biodegradation of the devicecomponents may be affected by a number of factors including, but notlimited to, the type of material from which it is formed, the shape ofthe device, and the deployment conditions. Additionally, altering thecross-sectional area or cross-sectional shape of the polymer filamentmay affect degradation time. For example, a hollow filament will likelyhave a different degradation time than a solid filament of comparablesize. As a result, choices of polymer filament materials and geometrymay be varied depending on the location and treatment desired.

Examples of biodegradable polymers that may be suitable for use with themethods and devices describe here include, but are not limited to,aliginate, cellulose and ester, dextran, elastin, fibrin, hyaluronicacid, polyacetals, polyarylates (L-tyrosine-derived or free acid),poly(α-hydroxy-esters), poly(β-hydroxy-esters), polyamides, poly(aminoacid), polyalkanotes, polyalkylene alkylates, polyalkylene oxylates,polyalkylene succinates, polyanhydrides, polyanhydride esters,polyaspartimic acid, polybutylene diglycolate, poly(caprolactone),poly(caprolactone)/poly(ethylene glycol) copolymers, poly(carbonate),L-tyrosine-derived polycarbonates, polycyanoacrylates,polydihidropyrans, poly(dioxanone), poly-p-dioxanone,poly(epsilon-caprolactone),poly(epsilon-caprolactone-dimethyltrimethylene carbonate),poly(esteramide), poly(esters), aliphatic polyesters, poly(etherester),poly(ethylene glycol)/poly(orthoester) copolymers, poly(glutarunicacid), poly(glycolic acid), poly(glycolide),poly(glycolide)/poly(ethylene glycol) copolymers,poly(glycolide-trimethylene carbonate), poly(hydroxyalkanoates),poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate), poly(iminocarbonates), polyketals, poly(lactic acid), poly(lactic acid-co-glycolicacid), poly(lactic acid-co-glycolic acid)/poly(ethylene glycol)copolymers, poly(lactide), poly(lactide-co-caprolactone),poly(DL-lactide-co-glycolide), poly(lactide-co-glycolide)/poly(ethyleneglycol) copolymers, poly(lactide)/poly(ethylene glycol) copolymers,poly(lactide)/poly(glycolide) copolymers, polyorthoesters,poly(oxyethylene)/poly(oxypropylene) copolymers, polypeptides,polyphosphazenes, polyphosphoesters, polyphosphoester urethanes,poly(propylene fumarate-co-ethylene glycol), poly(trimethylenecarbonate), polytyrosine carbonate, polyurethane, PorLastin orsilk-ealastin polymers, spider silk, tephaflex, terpolymer (copolymersof glycolide, lactide or dimethyltrimethylene carbonate), andcombinations, mixtures or copolymers thereof.

Drug Delivery

When the devices are configured for drug delivery, the amount of drugreleased from the device will depend on the desired dosage. Each drugshould be released at a rate that provides a patient with a healthy,safe, and effective dosage and should be administered at a dosage thatis also healthy, safe, and effective. In some variations, for examplewhen the devices are used to treat one or more conditions of thesinuses, the devices may be configured to deliver mometasone furoate ata daily dosage of about 500 μg or less per day. In other variations, thedevices are configured to deliver mometasone furoate at a daily dosageof about 200 μg, between about 5 μg to about 100 μg, between about 5 μgto about 60 μg, between about 5 μg to about 40 μg, between about 5 μg toabout 20 μg, between about 5 μg to about 10 μg, between about 10 μg toabout 100 μg, between about 10 μg to about 60 μg, between about 10 μg toabout 40 μg, between about 10 μg to about 20 μg, between about 20 μg toabout 100 μg, between about 20 μg to about 60 μg, between about 20 μg toabout 40 μg, between about 40 μg to about 100 μg, between about 40 μg toabout 60 μg, between about 60 μg to about 100 μg, and the like.

Drugs may be released at a constant rate from the device, but need notbe. Indeed, the devices may be configured with any suitable release rateprofile. In some variations, the daily amount of drug released maydecrease over time. For example, a device may release a certain amountof drug (e.g. between about 40 μg and about 60 μg) for a first period oftime (e.g. one week), then may release a second amount of drug (e.g.between about 20 μg and about 40 μg) for a second period of time.Similarly, the amount of drug delivered may change any number of timesduring a span of time. Furthermore, multiple drug eluting layers may beused, and each layer may be configured to have a different and specificrelease profile. Of course, it should be understood that each layer maycomprise, contain, include, or be configured to release one or more thanone drug or agent therefrom. When multiple layers are used each layermay comprise, contain, include, or be configured to release the same ora different drug or agent therefrom. Similarly, a filament comprisingdrug particles may be used to provide a different release profile fromthat of the drug eluting layer. Additionally, as described below, drugdepots may be used to achieve a varied release profile.

In still further variations, the device may comprise one or more barrierlayers. These layers may or may not release one or more drugs, and maydelay the release of one or more drugs from one or more drug releasinglayers. The barrier layer may or may not be a bulk-eroding polymer, ormay or may not be a surface-eroding polymer. In some variations, thebarrier layer may prevent the passage of drug therethrough. In thesevariations, the barrier layer may provide a time during which no drug isreleased from at least a portion of a drug releasing layer. Once thebarrier layer has sufficiently degraded or otherwise eroded, drugrelease may resume. In other variations, the barrier layer may allowsome amount drug to pass therethrough. In some of these variations, theamount of drug that passes through barrier layer may be less than thatwhich would be released from the drug releasing layer in the absence ofthe barrier layer. The barrier layer thus may provide a period duringwhich a smaller amount of drug is released from at least a portion ofthe drug releasing layer. Once the barrier layer has sufficientlydegraded or otherwise eroded, the amount of drug released from thedevice may increase.

These variations, and combinations thereof, may allow the device toprovide a variable drug release profile, or provide bursts, eitherinitial or delayed, in addition to the device's baseline releaseprofile. Additionally, these variations may allow the device to providedifferent drug release profiles that are separated in time. For example,the device may comprise two drug releasing layers separated by a barrierlayer. The outer drug releasing layer may release an initial amount ofdrug over an initial period of time, and may follow any suitable drugrelease profile. The barrier layer may then degrade or erode over acertain period of time, during which some or no drug is released from asecond drug releasing layer. Once this degradation has occurred, thesecond drug releasing layer may then release a second amount of drugover a second period of time, and this release may also follow anysuitable drug release profile. Each drug releasing layer may release anysuitable amount of any suitable drug over any suitable amount of time,as described above.

Additionally, one or more release rate modifiers may also be used. Therelease rate modifier may be any suitable biocompatible material thatserves to alter the rate at which a drug is released from the device. Insome variations, the release rate modifier may include a hydrophilicagent. In some variations, the release rate modifier is a polyethyleneglycol, e.g., a polyethylene glycol with a molecular weight of betweenabout 3000 to about 1300, between about 3000 to about 1100, betweenabout 3000 to about 900, between about 3000 to about 700, between about3000 to about 500, between about 5000 to about 1300, between about 5000to about 1100, between about 5000 to about 900, between about 5000 toabout 700, between about 7000 to about 1300, between about 7000 to about1100, between about 7000 to about 900, between about 9000 to about 1300,between about 9000 to about 1100, between about 11000 to about 1300, andthe like. In some variations, the release rate modifier is apolyethylene glycol with a molecular weight of about 6000.

In some variations, the device may be configured to deliver multipledrugs, which drugs may or may not be encapsulated (e.g., in amicroreservoir or other material). In some variations, multiple types ofdrug particles are contained within a single drug eluting layer. Inother variations, the drug eluting layer is discontinuous, havingdifferent sections containing different drugs. In these variations, thedifferent sections may have different compositions, and thus may alsoprovide differing release rates. In still other variations, multipledrug eluting layers may be used, where each layer contains a differentdrug or combination of drugs. Drug depots, as described above, may alsohold different drugs therein or may collectively release different drugsthan those released by the drug eluting layer. In still othervariations, the filament may release a different drug or combination ofdrugs than those drugs released by the drug eluting layer or layers. Anycombination of these variations may also be used to achieve the desireddrug delivery profiles.

Illustrative Agents

The device may comprise any suitable drug or agent, and the agentselected will largely be determined by the desired use of the device. Itshould be understood that the terms “agent” and “drug” are usedinterchangeably herein throughout. The device may comprise, for example,a diagnostic agent, or may comprise a therapeutic agent. Diagnosticagents may be used, for example, in diagnosing the presence, nature,and/or extent of a disease or medical condition in a subject. Thus forexample, the diagnostic agent may be any agent suitable for use inconnection with methods for imaging an internal region of a patientand/or diagnosing the presence or absence of a disease in a patient.

Diagnostic agents include, for example, contrast agents for use inconnection with ultrasound imaging, magnetic resonance imaging (MRI),nuclear magnetic resonance (NMR), computed tomography (CT), electronspin resonance (ESR), nuclear medical imaging, optical imaging,elastography, fluorescence imaging, positron emission tomography (PET),radiofrequency (RF) and microwave laser. Diagnostic agents may alsoinclude any other agent useful in facilitating diagnosis of a disease orother condition in a patient, whether or not imaging methodology isemployed.

Examples of specific diagnostic agents include radio-opaque materialssuch as iodine or iodine-derivatives, for example, iohexal andiopamidol. Other diagnostic agents such as, for example, radioisotopes,are detectable by tracing radioactive emissions. Examples of agentsdetectable by MRI are generally paramagnetic agents including, but notlimited to, gadolinium chelated compounds. An examples of an agentdetectable by ultrasound includes, but is not limited to, perflexane. Anexample of a fluorescence agent includes, but is not limited to,indocyanine green. Examples of agents used in diagnostic PET include,but are not limited to, fluorodeoxyglucose, sodium fluoride, methionine,choline, deoxyglucose, butanol, raclopride, spiperone, bromospiperone,carfentanil, and flumazenil.

The device may also comprise any suitable therapeutic agent. Suitableclasses of therapeutic agents include, for example, anti-inflammatoryagents, anti-allergens, anti-cholinergic agents, antihistamines,anti-infectives, anti-platelet agents, anti-coagulants, anti-thrombicagents, anti-scarring agents, anti-proliferative agents,chemotherapeutic agents, anti-neoplastic agents, decongestants, healingpromoting agents and vitamins (for example, retinoic acid, vitamin A,depaxapanthenol, vitamin B and their derivatives), hypersomolar agents,immunomodulators, immunosuppressive agents, and combinations andmixtures thereof.

Anti-infective agents generally include antibacterial agents, antifungalagents, antiparasitic agents, antiviral agents, and antiseptics.Anti-inflammatory agents generally include steroidal and nonsteroidalanti-inflammatory agents.

Examples of antiallergic agents that may suitable for use with thedescribed methods and devices include, but are not limited to,pemirolast potassium (ALAMAST®, Santen, Inc.), and any prodrugs,metabolites, analogs, homologues, congeners, derivatives, salts andcombinations thereof. Examples of antiproliferative agents include, butare not limited to, actinomycin D, actinomycin IV, actinomycin I₁,actinomycin X₁, actinomycin C₁, and dactinomycin (COSMEGEN®, Merck &Co., Inc.). Examples of antiplatelet, anticoagulant, antifibrin, andantithrombin agents include, but are not limited to, sodium heparin, lowmolecular weight heparins, heparinoids, hirudin, argatroban, forskolin,vapiprost, prostacyclin and prostacyclin analogues, dextran,D-phe-pro-arg-chloromethylketone (synthetic antithrombin), dipyridamole,glycoprotein IIb/IIIa platelet membrane receptor antagonist antibodies,recombinant hirudin, and thrombin inhibitors (ANGIOMAX®, Biogen, Inc.),and any prodrugs, metabolites, analogs, homologues, congeners,derivatives, salts and combinations thereof. Examples of pro-healingagents include, but are not limited to, sirolimus, everolimus,temsiolimus, and vitamin A.

Examples of cytostatic or antiproliferative agents that may be suitablefor uses with the described methods and devices include, but are notlimited to, angiopeptin, angiotensin converting enzyme inhibitors suchas captopril (CAPOTEN® and CAPOZIDE®, Bristol-Myers Squibb Co.),cilazapril or lisinopril (PRINIVIL® and PRINZIDE®, Merck & Co., Inc.);calcium channel blockers such as nifedipine; colchicines; fibroblastgrowth factor (FGF) antagonists, fish oil (omega 3-fatty acid);histamine antagonists; lovastatin (MEVACOR®, Merck & Co., Inc.);monoclonal antibodies including, but not limited to, antibodies specificfor Platelet-Derived Growth Factor (PDGF) receptors; nitroprusside;phosphodiesterase inhibitors; prostaglandin inhibitors; suramin;serotonin blockers; steroids; thioprotease inhibitors; PDGF antagonistsincluding, but not limited to, triazolopyrimidine; and nitric oxide, andany prodrugs, metabolites, analogs, homologues, congeners, derivatives,salts and combinations thereof.

Examples of antibacterial agents that may be suitable for use with thedescribed methods and devices include, but are not limited to,aminoglycosides, amphenicols, ansamycins, β-lactams such as penicillins,lincosamides, macrolides, nitrofurans, quinolones, sulfonamides,sulfones, tetracyclines, vancomycin, and any of their derivatives, orcombinations thereof. Examples of penecillins that may be suitable foruse with the described methods and devices include, but are not limitedto, amdinocillin, amdinocillin pivoxil, amoxicillin, ampicillin,apalcillin, aspoxicillin, azidocillin, azlocillin, bacampicillin,benzylpenicillinic acid, benzylpenicillin sodium, carbenicillin,carindacillin, clometocillin, cloxacillin, cyclacillin, dicloxacillin,epicillin, fenbenicillin, floxacillin, hetacillin, lenampicillin,metampicillin, methicillin sodium, mezlocillin, nafcillin sodium,oxacillin, penamecillin, penethamate hydriodide, penicillin Gbenethamine, penicillin G benzathine, penicillin G benzhydrylamine,penicillin G calcium, penicillin G hydrabamine, penicillin G potassium,penicillin G procaine, penicillin N, penicillin O, penicillin V,penicillin V benzathine, penicillin V hydrabamine, penimepicycline,phenethicillin potassium, piperacillin, pivampicillin, propicillin,quinacillin, sulbenicillin, sultamicillin, talampicillin, temocillin,and ticarcillin.

Examples of antifungal agents suitable for use with the describedmethods and devices include, but are not limited to, allylamines,imidazoles, polyenes, thiocarbamates, triazoles, and any of theirderivatives. Antiparasitic agents that may be employed include, but arenot limited to, atovaquone, clindamycin, dapsone, iodoquinol,metronidazole, pentamidine, primaquine, pyrimethamine, sulfadiazine,trimethoprim/sulfamethoxazole, trimetrexate, and combinations thereof.

Examples of antiviral agents suitable for use with the described methodsand devices include, but are not limited to, acyclovir, famciclovir,valacyclovir, edoxudine, ganciclovir, foscamet, cidovir (vistide),vitrasert, formivirsen, HPMPA(9-(3-hydroxy-2-phosphonomethoxypropyl)adenine), PMEA(9-(2-phosphonomethoxyethyl)adenine), HPMPG(9-(3-Hydroxy-2-(Phosphonomet-hoxy)propyl)guanine), PMEG(9-[2-(phosphonomethoxy)ethyl]guanine), HPMPC(1-(2-phosphonomethoxy-3-hydroxypropyl)-cytosine), ribavirin, EICAR(5-ethynyl-1-beta-D-ribofuranosylimidazole-4-carboxamine), pyrazofurin(3-[beta-D-ribofuranosyl]-4-hydroxypyrazole-5-carboxamine),3-Deazaguanine, GR-92938X(1-beta-D-ribofuranosylpyrazole-3,4-dicarboxami-de), LY253963(1,3,4-thiadiazol-2-yl-cyanamide), RD3-0028(1,4-dihydro-2,3-Benzodithiin), CL387626(4,4′-bis[4,6-d][3-aminophenyl-N-,N-bis(2-carbamoylethyl)-sulfonilimino]-1,3,5-triazin-2-ylamino-biphenyl-2-,2′-disulfonicacid disodium salt), BABIM (Bis[5-Amidino-2-benzimidazoly-1]-methane),NIH351, and combinations thereof.

Examples of antiseptic agents suitable for use with the describedmethods and devices include, but are not limited to, alcohol,chlorhexidrine, iodine, triclosan, hexachlorophene, and silver-basedagents, for example, silver chloride, silver oxide, and silvernanoparticles.

Anti-inflammatory agents may include steroidal and nonsteroidalanti-inflammatory agents. Examples of suitable steroidalanti-inflammatory agents include, but are not limited to,21-acetoxypregnenolone, alclometasone, algestone, amcinonide,beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol,clobetasone, clocortolone, cloprednol, corticosterone, cortisone,cortivazol, deflazacort, desonide, desoximetasone, dexamethasone,diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort,flucloronide, flumethasone, flunisolide, fluocinolone acetonide,fluocinonide, fluocortin butyl, fluocortolone, fluorometholone,fluperolone acetate, fluprednidene acetate, fluprednisolone,flurandrenolide, fluticasone propionate, formocortal, halcinonide,halobetasol propionate, halometasone, halopredone acetate,hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone,medrysone, meprednisone, methylprednisolone, mometasone furoate,paramethasone, prednicarbate, prednisolone, prednisolone25-diethylamino-acetate, prednisolone sodium phosphate, prednisone,prednival, prednylidene, rimexolone, tixocortol, triamcinolone,triamcinolone acetonide, triamcinolone benetonide, triamcinolonehexacetonide, any of their derivatives, and combinations thereof.

Examples of suitable nonsteroidal anti-inflammatory agents include, butare not limited to, COX inhibitors. These COX inhibitors may includeCOX-1 or COX nonspecific inhibitors such as, for example, salicylic acidderivatives, aspirin, sodium salicylate, choline magnesiumtrisalicylate, salsalate, diflunisal, sulfasalazine and olsalazine;para-aminophenol derivatives such as acetaminophen; indole and indeneacetic acids such as indomethacin and sulindac; heteroaryl acetic acidssuch as tolmetin, dicofenac and ketorolac; arylpropionic acids such asibuprofen, naproxen, flurbiprofen, ketoprofen, fenoprofen and oxaprozin;anthranilic acids (fenamates) such as mefenamic acid and meloxicam;enolic acids such as the oxicams (piroxicam, meloxicam) and alkanonessuch as nabumetone. The COX inhibitors may also include selective COX-2inhibitors such as, for example, diaryl-substituted furanones such asrofecoxib; diaryl-substituted pyrazoles such as celecoxib; indole aceticacids such as etodolac and sulfonanilides such as nimesulide).

Examples of chemotherapeutic/antineoplastic agents that may be used inthe devices described here include, but are not limited to antitumoragents (e.g., cancer chemotherapeutic agents, biological responsemodifiers, vascularization inhibitors, hormone receptor blockers,cryotherapeutic agents or other agents that destroy or inhibit neoplasiaor tumorigenesis) such as alkylating agents or other agents whichdirectly kill cancer cells by attacking their DNA (e.g.,cyclophosphamide, isophosphamide), nitrosoureas or other agents whichkill cancer cells by inhibiting changes necessary for cellular DNArepair (e.g., carmustine (BCNU) and lomustine (CCNU)), antimetabolitesor other agents that block cancer cell growth by interfering withcertain cell functions, usually DNA synthesis (e.g., 6-mercaptopurineand 5-fluorouracil (5FU), antitumor antibiotics and other compounds thatact by binding or intercalating DNA and preventing RNA synthesis (e.g.,doxorubicin, daunorubicin, epirubicin, idarubicin, mitomycin-C andbleomycin), plant (vinca) alkaloids and other anti-tumor agents derivedfrom plants (e.g., vincristine and vinblastine), steroid hormones,hormone inhibitors, hormone receptor antagonists and other agents whichaffect the growth of hormone-responsive cancers (e.g., tamoxifen,herceptin, aromatase ingibitors such as aminoglutethamide andformestane, triazole inhibitors such as letrozole and anastrazole,steroidal inhibitors such as exemestane), antiangiogenic proteins, smallmolecules, gene therapies and/or other agents that inhibit angiogenesisor vascularization of tumors (e.g., meth-1, meth-2, thalidomide),bevacizumab (Avastin), squalamine, endostatin, angiostatin, Angiozyme,AE-941 (Neovastat), CC-5013 (Revimid), medi-522 (Vitaxin),2-methoxyestradiol (2ME2, Panzem), carboxyamidotriazole (CAI),combretastatin A4 prodrug (CA4P), SU6668, SU11248, BMS-275291, COL-3,EMD 121974, IMC-1C11, IM862, TNP-470, celecoxib (Celebrex), rofecoxib(Vioxx), interferon alpha, interleukin-12 (IL-12) or any of thecompounds identified in Science Vol. 289, Pages 1197-1201 (Aug. 17,2000), which is expressly incorporated herein by reference, biologicalresponse modifiers (e.g., interferon, bacillus calmette-guerin (BCG),monoclonal antibodies, interleukin 2, granulocyte colony stimulatingfactor (GCSF), etc.), PGDF receptor antagonists, herceptin,asparaginase, busulphan, carboplatin, cisplatin, carmustine,cchlorambucil, cytarabine, dacarbazine, etoposide, flucarbazine,fluorouracil, gemcitabine, hydroxyurea, ifosphamide, irinotecan,lomustine, melphalan, mercaptopurine, methotrexate, thioguanine,thiotepa, tomudex, topotecan, treosulfan, vinblastine, vincristine,mitoazitrone, oxaliplatin, procarbazine, streptocin, taxol orpaclitaxel, taxotere, azathioprine, docetaxel analogs/congeners,derivatives of such compounds, and combinations thereof.

Examples of decongestants that may be used in the devices and methodsdescribed here include, but are not limited to, epinephrine,pseudoephedrine, oxymetazoline, phenylephrine, tetrahydrozolidine, andxylometazoline. Examples of mucolytics that may be used in the devicesand methods described here include, but are not limited to,acetylcysteine, dornase alpha, and guaifenesin. Anti-histamines such asazelastine, diphenhydramine, and loratidine may also be used in themethods and devices described here.

Suitable hyperosmolar agents that may be used in the devices describedhere include, but are not limited to, furosemide, sodium chloride gel,and other salt preparations that draw water from tissue or substancesthat directly or indirectly change the osmolarity of the mucous layer.

Other bioactive agents useful in the present invention include, but arenot limited to, free radical scavengers; nitric oxide donors; rapamycin;methyl rapamycin; everolimus; tacrolimus;40-O-(3-hydroxy)propyl-rapamycin;40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin; tetrazole containingrapamycin analogs such as those described in U.S. Pat. No. 6,329,386;estradiol; clobetasol; idoxifen; tazarotene; alpha-interferon; hostcells including, but not limited to prokaryotes and eukaryotes such as,for example, epithelial cells and genetically engineered epithelialcells; dexamethasone; and, any prodrugs, metabolites, analogs,homologues, congeners, derivatives, salts and combinations thereof.

Examples of free radical scavengers include, but are not limited to,2,2′,6,6′-tetramethyl-1-piperinyloxy, free radical (TEMPO);4-amino-2,2′,6,6′-tetramethyl-1-piperinyloxy, free radical(4-amino-TEMPO); 4-hydroxy-2,2′,6,6′-tetramethyl-piperidene-1-oxy, freeradical (TEMPOL), 2,2′,3,4,5,5′-hexamethyl-3-imidazolinium-1-yloxymethyl sulfate, free radical; 16-doxyl-stearic acid, free radical;superoxide dismutase mimic (SODm) and any analogs, homologues,congeners, derivatives, salts and combinations thereof. Nitric oxidedonors include, but are not limited to, S-nitrosothiols, nitrites,N-oxo-N-nitrosamines, substrates of nitric oxide synthase, diazeniumdiolates such as spermine diazenium diolate, and any analogs,homologues, congeners, derivatives, salts and combinations thereof.

Delivery Devices

Also described here are delivery devices which may be used to deliverone or more of the self-expanding devices described above. Whilegenerally described here as being used to deliver the self-expandingdevices described above, it is important to realize that the deliverydevices may be used to deliver any suitable implant or implants. Indeed,the delivery devices may be used to deliver one or more self-expandingdevices, non-expanding devices, expandable devices, swellable devices,shape-changing devices, a combination thereof, or the like. The implantor implants delivered may have any suitable size, shape, andconfiguration, and in some instances may be tailored to the anatomy intowhich the implant will be delivered, which may be any suitable portionof the anatomy. For example, in some variations the delivery devices maydeliver one or more implants to one or more of the paranasal sinuses. Inother variations, the delivery devices may be used to deliver one ormore devices to other portions of the anatomy, such as the Eustachiantube, the urethra, or the tonsils.

The delivery devices typically comprise a cannula defining a lumen,aperture or other opening for retaining an implant therein. When thedelivery device is used to deliver a self-expanding device, the deliverydevice may be configured to house the self-expanding device in acompressed or unexpanded configuration. The delivery devices may beoperated single-handedly and may be ergonomically designed to help theoperator deliver and deploy the device. In some variations, endoscopicguidance, or other forms of visualization, such as ultrasound orfluoroscopy, may be used to aid in delivery. The delivery device may beconfigured for a single use (e.g., be terminally sterilized with e-beamradiation) or may be configured for multiple uses (e.g., be capable ofbeing sterilized multiple times). In some variations, one or morecomponents of the delivery device may be configured for a single usewhile one or more components may be configured for multiple uses.

FIG. 5A depicts one variation of a suitable delivery device. As shownthere, delivery device (500) comprises a cannula (502) defining a lumen(not shown), inside which one or more implants may be housed. Also shownthere is pusher (504) which is connected to plunger (508) and isslidably disposed within handle body (510). While the deploymentactuation shown here is in the form of a push rod mechanism, anysuitable actuation mechanism may be used, as will be described in moredetail below. In the variation shown in FIG. 5A, pusher (504) isslidable within the lumen of the cannula (502), so that as plunger (508)is moved distally relative to handle body (510), pusher (504) isadvanced distally and may force an implant from the cannula's distalend.

In the variation shown in FIG. 5A, the proximal end of the cannula (502)is connected to handle body (510). In some variations, this connectionmay be reversible or releasable such that the cannula (502) may bedisengaged from handle body (510). The handle body (510) may help enablesingle-handed use, and provide for an intuitive and ergonomic userinterface. For example, the handle body (510) shown in FIG. 5A isdesigned so that the operator will grip it in a “pen-like” fashion,while actuating the plunger (508) to deliver the implant as describedabove. FIG. 5B depicts another variation of delivery device (512) havinga similar configuration of elements, but designed to be held in a“syringe-like” fashion. Shown there is cannula (514), handle body (516)comprising grips (518), and plunger (520) attached to pusher (522). Inthese variations, an operator may use one or more fingers to grasp grips(518), and may apply pressure to plunger (520) (e.g., with one's thumb)to advance pusher (522).

Cannula

While shown in FIGS. 5A and 5B as having a single curve at the distalportion thereof, the cannula may be shaped in any manner and may haveany number of shaped curves. In some variations, the cannula may bepre-shaped. In other variations, the shape of the cannula may be set orchanged during delivery. In variations that include one or more shapedcurves, the shaped curves may have any suitable dimensions. Indeed, FIG.5C illustrates a curved cannula (526), and highlights some of therelevant dimensions that may be associated with the shaped curve. Shownthere is cannula (526) having a curve (528) with a radius of curvature(R), an angle (θ), and a curve height (H). These dimensions may be ofany suitable value or range, depending on the intended use of the deviceand the size of the intended implant.

For example, when delivering implants to the frontal sinuses or themaxillary sinuses, curve (528) may have any suitable angle (θ). Suitableangles (θ) include, but are not limited to, about 50°, about 60°, about70°, about, 80°, about 90°, about 100°, about 110°, and about 120°. Insome variations the angle (θ) may between about 50° and about 120°,between about 60° and about 120°, between about 70° and about 120°,between about 80° and 120°, between about 90° and about 120°, betweenabout 100° and about 120°, between about 110° and about 120°, betweenabout 50° and about 110°, between about 60° and about 110°, betweenabout 70° and about 110°, between about 80° and about 110°, betweenabout 90° and about 110°, between about 100° and 110°, between about 50°and about 100°, between about 60° and about 100°, between about 70° andabout 100°, between about 80° and about 100°, between about 90° andabout 100°, between about 50° and about 90°, between about 60° and about90°, between about 70° and about 90°, between about 80° and about 90°,between about 50° and about 80°, between about 60° and about 80°,between about 70° and about 80°, between about 50° and about 70°,between about 50° and about 70°, or between about 60° and about 70°.Furthermore, suitable radii of curvature (R) for delivery to the frontalsinuses include, but are not limited to about 6 mm, about 7 mm, about 8mm, about 9 mm, about 10 mm, about 11 mm and about 12 mm. In somevariations the radius of curvature (R) may be between about 6 mm andabout 12 mm, between about 7 mm and about 12 mm, between about 8 mm andabout 12 mm, between about 8 mm and about 12 mm, between about 9 mm andabout 12 mm, between about 10 mm and about 12 mm, between about 11 mmand about 12 mm, between about 6 mm and about 11 mm, between about 7 mmand about 11 mm, between about 8 mm and about 11 mm, between about 9 mmand about 11 mm, between about 10 mm and about 11 mm, between about 6 mmand about 10 mm, between about 7 mm and about 10 mm, between about 8 mmand about 10 mm, between about 9 mm and about 10 mm, between about 6 mmand about 9 mm, between about 7 mm and about 9 mm, between about 8 mmand about 9 mm, between about 6 mm and about 8 mm, between about 7 mmand about 8 mm, or between about 6 mm and about 7 mm. Suitable heights(H) for delivery to the frontal or maxillary sinuses include, but arenot limited to, about 23 mm, about 25 mm, about 28 mm, and about 30 mm.Additionally, in some variations height (H) may be between about 23 mmand about 30 mm, between about 25 mm and about 30 mm, between about 28mm and about 30 mm, between about 23 mm and about 28 mm, between about25 mm and about 28 mm, or between about 23 mm and about 25 mm.

Similarly, when delivering implants to the ethmoid sinuses, suitableangles (θ) include, but are not limited to, about 10°, about 20°, about30°, about 40°, about 50°, about 60°, about 70°, about 80°, about 90°,about 100°, and about 110°. In some variations, the angle (θ) may bebetween about 10° and about 110°, between about 30° and about 110°,between about 50° and about 110°, between about 70° and about 110°,between about 90° and about 110°, between about 10° and about 90°,between about 30° and about 90°, between about 50° and about 90°,between about 70° and about 90°, between about 10° and about 70°,between about 30° and about 70°, between about 50° and about 70°,between about 10° and about 50°, between about 30° and about 50°, orbetween about 10° and about 30°. Examples of suitable radii of curvature(R) for delivery to the ethmoid sinuses include, but are not limited toabout 17 mm, about 19 mm, about 21 mm, about 23 mm, about 25 mm, andabout 27 mm. In some variations, the radius of curvature (R) may bebetween about 17 mm and about 27 mm, between about 19 mm and about 27mm, between about 21 mm and about 27 mm, between about 23 mm and about27 mm, between about 25 mm and about 27 mm, between about 17 mm andabout 25 mm, between about 19 mm and about 25 mm, between about 21 mmand about 25 mm, between about 23 mm and about 25 mm, between about 17mm and about 23 mm, between about 19 mm and about 23 mm, between about21 mm and about 23 mm, between about 17 mm and about 21 mm, betweenabout 19 mm and about 21 mm, or between about 17 mm and about 19 mm.Suitable heights (H) for delivery to the frontal or maxillary sinusesinclude, but are not limited to, about 23 mm, about 25 mm, about 28 mm,and about 30 mm. Additionally, in some variations height (H) may bebetween about 23 mm and about 30 mm, between about 25 mm and about 30mm, between about 28 mm and about 30 mm, between about 23 mm and about28 mm, between about 25 mm and about 28 mm, or between about 23 mm andabout 25 mm.

Additionally, the cannula may define an inner diameter that may houseimplants of any number of sizes. The inner diameter of the cannula mayor may not be constant along the length of the cannula. Indeed, in somevariations the inner diameter of the cannula may vary throughout thelength of the cannula, or the cannula may be made of a material that maystretch or deform when holding an implant therein. In some of thesevariations, the inner diameter of the cannula may be substantiallysmaller than one or more implants to be delivered, but may stretch toaccommodate the one or more implants. By allowing the cannula to have asmaller profile while still being able to hold the same-sized implant,an operator is given additional space in the body into which otherdevices, such as an endoscope, may be placed.

Examples of suitable inner diameters of the cannula include, but are notlimited to, about 0.05 mm, about 1 mm, about 2 mm, about 3 mm, about 4mm, about 5 mm, about 6 mm, or greater than about 7 mm. In somevariation the inner diameter may be between about 0.05 mm and about 6mm, between about 1 mm and about 6 mm, between about 2 mm and about 6mm, between about 3 mm and about 6 mm, between about 3 mm and about 6mm, between about 4 mm and about 6 mm, between about 5 mm and about 6mm, between about 0.05 mm and about 5 mm, between about 1 mm and about 5mm, between about 2 mm and about 5 mm, between about 3 mm and about 5mm, between about 4 mm and about 5 mm, between about 0.05 mm and about 4mm, between about 1 mm and about 4 mm, between about 2 mm and about 4mm, between about 3 mm and about 4 mm, between about 0.05 mm and about 3mm, between about 1 mm and about 3 mm, between about 2 mm and about 3mm, between about 0.05 mm and about 2 mm, between about 1 mm and about 2mm, or between about 0.05 mm and about 1 mm.

As mentioned above, in some variations the shape of the cannula may beset or changed during operation of the device. Indeed, while one or moreportions of the cannula may be preset in shape, one or more portions ofthe cannula may be flexible, bendable, or otherwise lacking in a setshape. In some of these variations, one or more inserts may be placedinto the cannula to give any flexible portions a set shape. Theseinserts may be any size, shape, or configuration. In some variations,the insert may be a rigid tube. In other variations, the insert may be arigid wire. These variations may find particular utility in instanceswhen the cannula has two or more lumens, as will be described in moredetail below.

In other variations, the cannula may be steerable or have one or morefeatures that may lock an otherwise flexible cannula into a set shape.The cannula may or may not be configured for remote or roboticoperation, and may or may not have one or more articulated orarticulable segments. FIGS. 23A and 23B illustrate one variation of asteerable and lockable delivery device (2300). Shown there is flexiblecannula (2302), skeleton (2304), and left (2306) and right (2308)control lines for controlling cannula (2302). Skeleton (2304) may beconfigured to freely flex between a straight configuration, as shown inFIG. 23A, a left-curved configuration, as shown in FIG. 23B, and aright-curved configuration (not shown). This free movement may beconstrained by placing tension on one or both of left (2306) and right(2308) control lines. More specifically, if equal tension is placed onboth left (2306) and right (2308) control lines, then the cannula (2302)may be held in the straight configuration shown in FIG. 23A. If greatertension is placed on left control line (2306), then cannula (2302) maybend to the left. Conversely, if greater tension is placed on rightcontrol line (2308), cannula (2302) may bend to the right. Depending onthe amount of tension placed on left (2306) and right (2308) controllines, cannula (2302) may be held in a certain configuration despiteexternally applied forces. In some variations the delivery device isconfigured such that the device naturally places left (2306) and right(2308) control lines under a predetermined amount of tension, and theuser may temporarily release the tension to allow cannula (2302) tobecome flexible. It is important to note that although delivery device(2300) is shown in FIGS. 23A and 23B as having two control lines and acannula (2302) that is able to bend in two directions, delivery device(2300) may have any number of control lines and cannula (2302) may ableto bend in any corresponding number of directions. Indeed, cannula(2300) may have one, two, three, or four or more control lines, and mayhave a skeleton (2304) that may bend cannula (2302) in one, two, three,or four or more directions.

The cannula may be made of any suitable or desirable material. Examplesof suitable cannula materials include, but are not limited to, polyvinylchloride, Pebax®, polyethylene, silicone rubber, polyurethane, and anyanalogs, homologs, congeners, derivatives, copolymers, and mixturesthereof. In some variations, the cannula may comprise one or more metalsor metal alloys, such as, but not limited to, magnesium, nickel-cobaltalloys, nickel-titanium alloys, copper-aluminum-nickel alloys,copper-zinc-aluminum-nickel alloys, combinations thereof and the like.The cannula may be made of one material, or may be made from a mixtureor combination of different materials. In some variations, one portionof the cannula may be made of one or more materials, while anotherportion of the cannula may be made from a different material orcombination of materials. In other variations, one or more portions ofthe cannula may be braided to increase the strength or rigidity of thecannula. Additionally, the cannula may or may not be made of translucentor transparent materials. Transparent or translucent materials may allowan operator to directly visualize an implant's positioning while theimplant is housed within the cannula.

The distal end, or tip, of the cannula may have any suitable dimensionsor configuration. For example, the cannula tip may or may not have thesame diameter as the rest of the cannula. Similarly, the cannula tip mayor may not be made of the same material or materials as the rest of thecannula. In some variations the cannula tip is made of a soft,atraumatic material, in order to minimize damage during delivery anddeployment. Additionally, the shape of the cannula or cannula tip mayhelp minimize damage during delivery and deployment. For example, theedges of the cannula tip may be rounded or beveled to further minimizetissue trauma. In some of these variations, the cannula tip may bedeformable. In these variations, an operator may deform a cannula tipeither before or after one or more implants have been placed within thecannula. For example, an operator may use one or more tools to compressa cannula tip having a circular cross-sectional shape, which may deformthe tip to take on an oval cross-sectional shape. This may allow the tipto more easily pass through adjoining tissues. Additionally, the tip mayagain be deformed when the one or more implants is ejected from thecannula.

In some variations, the cannula tip may include one or more features orcomponents that may aid in advancement of the delivery device ordelivery/deployment of one or more implants. FIGS. 24A-24Q illustratedifferent variations of suitable cannula tips. It is important to notethat the tip features or components described here may or may not beintegral to the cannula tip. Indeed, any of the cannula tips describedhere may be formed separately from, and later attached to, the deliverydevice. These attachable tips may be configured to attach to thestandard, cylindrical cannula tip, as shown in FIGS. 5A and 5B, or maybe configured to attach to any one of the cannula tips described below.Attachable tips may provide a user considerable leeway in choosing acannula tip that is appropriate for a given set of circumstances withoutneeding to replace the entire cannula or delivery device. Theseattachable tips may be attached in any suitable manner, including, butnot limited to, press fitting, welding (e.g. heat welding, ultrasonicwelding, tacking, staking, and the like), chemical bonding, mechanicalattachment (sutures, clamps, clips or other mechanical fasters), orattachment using adhesives (glues, adhesive polymers and the like) orother materials (sugars, low melting-temperature polymers and the like),or some combination thereof. The attachable tips may or may notpermanently attach to the cannula. Indeed, in some variations theattachable tips may be releasably attached to the cannula. Whenreleasable, the attachable tips may be released within the body, or maybe released outside of the body. When released in a body, an attachabletip may or may not be biodegradable, and may or may not be removed byaspiration or another suitable manner. Additionally, the attachable tipsmay serve an additional function in the body such as drug delivery,stenting, or acting as a marker.

In some variations, the cannula tip may comprise one or more markersthat may aid in visualization of the cannula. FIG. 24A depicts one suchvariation of cannula tip (2400) having marker (2402). In somevariations, marker (2402) may be configured to aid in directvisualization of the cannula. Indeed, when the cannula is substantiallytransparent, the marker may be opaque or otherwise non-transparent,which may in turn allow an operator to identity and differentiate thecannula tip from the cannula body. Similarly, the marker may be of adifferent color from the cannula body, or may reflect different amountsof light than the cannula body. Marker (2402) may or may not be aradiographic or ultrasonic marker, and may or may not aid in indirectvisualization of the cannula through methods such as ultrasound andfluoroscopy. In still other variations, marker (2402) is configured toemit one or more signals that may be detected by one or morevisualization devices. Cannula tip (2400) may additionally have anynumber or combination of markers as described above.

FIGS. 24B and 24C show another variation of cannula tip (2404)comprising an expandable funnel-shaped tip (2406). Funnel-shaped tip(2406) may or may not be collapsible to a low profile configuration, asshown in FIG. 24B. Funnel-shaped tip (2406) may be held in a low profileconfiguration by a sheath or other restraining device (not shown) andwhen expanded may aid an operator in positioning the cannula tip (2404)relative to an opening, such as a sinus ostium. Once cannula tip (2404)has been passed through the opening, the sheath or restraining devicemay be removed, and funnel-shaped tip (2406) may expand to an expandedconfiguration, as shown in FIG. 24C. Funnel-shaped tip (2406) may or maynot self-expand to its expanded configuration, and may or may not beconfigured to expand in response to one or more stimuli. Additionally,while shown in FIG. 24C as being frustoconical in shape, funnel-shapedtip may have any cross-sectional profile. Once funnel-shaped tip (2406)is expanded, the cannula may be withdrawn proximally relative to theopening. The increasing diameter of funnel-shaped tip (2406) may resistpassage through the opening, which may provide a user with tactilefeedback of the cannula tip's positioning relative to the opening. Oncethe one or more implants have been delivered, the funnel-shaped tip(2406) may or may not be withdrawn into the restraining device to resumeits low-profile configuration.

A funnel-shaped tip (2406) may also aid in controlled delivery of one ormore self-expanding devices. For example, funnel-shaped tip (2406) maybe used to help ensure implant placement adjacent to a tissue wall. Onceexpanded, funnel-shaped tip (2406) may be placed against a tissue wall,and the self-expanding device may be advanced into funnel-shaped tip(2406) where the self-expanding device may at least partially expand.Funnel-shaped tip (2406) may then be withdrawn away from the tissue wallto leave the implant in place.

Additionally, in some variations cannula tip may have one or moreprotrusions. FIG. 24D shows one such variation of cannula tip (2408)comprising olive tip (2410). Olive tip (2410) may aid in dilation of apassage opening and may temporarily or permanently displace one or moreobstructions such as a nasal polyp. Furthermore, due to its roundednature, olive tip (2410) may reduce the risk of tissue damage that maybe sustained in dilation or displacement. Additionally, depending on thedimensions of olive tip (2410), olive tip (2410) may have a sealingfunction when it engages an opening. This may allow a user to introducea fluid through the cannula without the fluid passing through theopening, which may provide particular utility in instances where it isdesirable to flush or fill a sinus with a liquid or gas without thatliquid or gas leaving the sinus cavity through the sinus ostium.

While shown in FIG. 24D as being olive-shaped, cannula tip (2408) mayhave a protrusion of any suitable shape, dimensions or configuration ofelements, which may be located anywhere along the length of cannula tip(2408). Indeed, the protrusion may be wedge-shaped, frustoconical, oval,or have any three-dimensional shape of regular or irregular geometry. Insome of these variations, the protrusion may provide or more additionalfunctions. For example, FIG. 24E depicts cannula tip (2412) comprising awedge-shaped protrusion (2414). In addition to the potential dilating,displacing, or sealing functions described above, a wedge-shaped tip mayprovide a structure that allows an attachable tip may be removed fromthe cannula. The wedge-shaped protrusion (2414) may be passed through anopening (not shown), potentially temporarily dilating that opening inthe process. If the widest diameter of the wedge shaped portion (2414)is wider than the diameter of the opening, the opening may resist areturn trip of the cannula tip (2412) through the opening. Assumingwedge-shaped portion (2414) is a part of an attachable tip, thisresistance may provide a force sufficient to release the attachable tipfrom the cannula.

FIGS. 24F and 24G show a frontal view and a side view, respectively, ofanother variation of cannula tip (2416) having a plate extension (2418).Plate extension (2418) may be substantially flat, or may have one ormore curves. Generally speaking, plate extension (2418) provides a lowerprofile portion that may allow cannula tip (2416) to maneuver betweenadjoining tissues. Because the plate extension (2418) is thinner thanthe body (2420) of cannula tip (2416) along one plane, as illustrated inFIG. 24G, plate extension (2418) may be better able to wedge between twotouching tissues (not shown). Once the plate extension (2418) has beenplaced within two tissues, the cannula tip (2416) may or may not berotated to separate the two tissues. In some variations, the plateextension (2418) increases in thickness or curves to join with body(2420).

Additionally, plate extension (2418) may allow for directional deliveryof one or more implants. For example, when a self-expanding device ispassed out of the aperture (2422) of cannula tip (2416), plate extension(2418) may limit the directions in which the self-expanding device mayexpand relative to cannula tip (2416). For instance, if cannula tip(2416) is positioned as shown in FIG. 24G, a self-expanding device, whenreleased from aperture (2422), may expand toward the left. Thisdirectional expansion may allow a user to control the placement andexpansion of a self-expanding member. For example, a user may positioncannula tip (2416) and plate extension (2418) next to a tissue wall (notshown). As a self-expanding device is released from aperture (2422), itsexpansion may be constrained by the tissue wall on one side and theplate extension (2418) on the other. A user may then move cannula tip(2416) away from the tissue wall to allow the self-expanding device tocontinue expanding.

Still other cannula tips may comprise one or more slots or prongs.Indeed, FIGS. 24H and 24I illustrate a variation of cannula tip (2424)comprising slots (2426) and prongs (2428). The cannula tip (2424) maycomprise any suitable number of slots (2426) and prongs (2428) (e.g.,one, two, three, four, five six, seven, eight, or nine or more),although generally the number of slots (2426) and prongs (2428) will bethe same. Additionally, each slot (2426) and prong (2428) may have anysuitable size, shape, and configuration, and each slot (2426) and prong(2428) may or may not have the same size, shape, or configuration.Indeed, slots (2426) and prongs (2428) may be rectangular, triangular,curved, sinusoidal, or may have one or more shapes with irregulargeometry. It is important to note, however, that the size and shape ofeach slot (2426) will be determined by the shape and relativepositioning of the prongs (2428) on either side of it. Furthermore,while shown in FIGS. 24H and 24I as being oriented parallel to thecannula's longitudinal axis, slots (2426) and prongs (2428) may beangled relative to the cannula's longitudinal axis.

Additionally, a cannula tip (2424) comprising slots (2426) and prongs(2428) may aid in the delivery of one or more implants. In someinstances, an implant (2430) may comprise one or more protrusions (2432)that may project through one or more slots (2426) when the implant(2430) is housed within the cannula, as shown in FIG. 24I. When thedelivery device is withdrawn proximally, one or more of the protrusions(2432) may engage surrounding tissue. As the delivery device continuesto be withdrawn, the implant (2430) may be held in place by thisengagement and may be pulled out of the cannula. Additionally, theprotrusions (2432) may be configured to help minimize damage done byprotrusions (2432) to tissue when the delivery device is advancedthrough the body. For example, protrusions (2432) may be angled awaytoward the distal end of the cannula, or may have one-way flexibilitythat allows the protrusions (2432) to be pressed against the body of thecannula.

The prongs may or may not be substantially rigid, and may or may not beable to bend, flex, or deform in response to one or more forces orstimuli. In variations where the prongs are able to bend, flex, ordeform in response to a force or stimulus, prongs may aid in thecontrolled release of self-expanding device. Depending on the size,shape, and configuration of the self-expanding device, in some instancesthe self-expanding device may have a tendency to “spring” from a cannulatip, and moveable prongs may be able to otherwise prevent this springingby allowing for controlled expansion. FIG. 24J depicts one suchvariation of cannula tip (2434) comprising slots (2436) and prongs(2438), with prongs (2438) bent away from cannula tip (2434). In thevariation shown in FIG. 24J, prongs (2438) may be substantially rigid,but may be able to bend away from cannula tip (2434) at attachmentpoints (2440). In other variations, one or more of the prongs (2438) mayor may not be made from a fabric such as felt or another material thatreadily deforms.

In some instances, the expansion force provided by a self-expandingmember may be sufficient to cause the prongs to bend, flex, or deform.In these variations, a device may be released from the cannula tip inany suitable fashion. In some variations, the self-expanding device maybe held within the prongs, and the prongs may in turn be held by thesheath or holder. Once the sheath or holder is withdrawn relative to theprongs, the prongs may bend, flex, or deform in response to theexpansion of the self-expanding device. In other variations, aself-expanding device may be advanced from the body of the cannula intothe tip to cause the prongs to bend, flex, or deform.

In still other variations, the prongs may be configured to naturallybend, flex, or deform away from the cannula tip. These variations mayprovide particular utility where it is desirable to position the cannulatip relative to an opening such as a sinus ostium. In these variations,the prongs may be held in an unexpanded configuration by a sheath orholder, and the cannula tip may be advanced through an opening. Oncethrough the opening, the sheath or holder may be withdrawn to releasethe prongs and thereby allow them to naturally bend, flex, or deformaway from the cannula tip. The released prongs may resist beingwithdrawn through the opening, and thus may provide a user with tactilefeedback that indicates to the user that the cannula tip is in contactwith the opening.

In some variations where the cannula tip comprises slots and prongs, theslots may be directed inward toward the center of the cannula tip. FIG.24K depicts one such variation of cannula tip (2442) comprising slots(2444) and inwardly directed prongs (2448). Because this configurationreduces the profile of the cannula tip (2442), the inwardly directedprongs (2448) may provide particular utility in navigating throughnarrow spaces or separating adjoining tissues. Additionally, cannula tip(2442) may be configured to move the inwardly directed prongs (2448) inorder to allow one or more implants to be delivered from the end ofcannula tip (2442). In some instances, merely advancing one or moreimplants through the cannula tip (2442) may provide sufficient force toseparate the prongs. In other variations, the prongs (2448) may beconfigured to bend or flex away from their low profile configurationupon application of one or more stimuli to the cannula tip (2442). Instill other variations, a balloon or other expandable member (not shown)disposed within cannula tip (2442) may be expanded to separate theprongs (2448). The balloon or other expandable member may or may notdefine a lumen or aperture through which one or more implants may pass.Additionally, when the prongs (2448) are separated, they may aid inpositioning cannula tip (2442) relative to an opening, as describedabove.

Inwardly directed prongs may also be configured to puncture one or moretissues such as an ethmoid bulla. FIG. 24L shows a suitable variation ofcannula tip (2450) having prongs (2452) and slots (2454). As shown inFIG. 24L, prongs (2452) may be shaped such that they approximate a pointwhen directed inward toward the center of the cannula tip (2450). Thispoint may or may not be sufficiently sharp to allow cannula tip (2450)to puncture tissue. Additionally, in some instances it may desirable forany tissue puncture to be substantially rounded and free of tissuefragments. As such, it may be desirable for the cannula tip (2450) to befree of any gaps from slots (2454). Thus, as shown in FIG. 24L, prongs(2452) may be configured such that slots (2454) are essentiallyeliminated when the prongs (2452) are directed inward. While shown inFIG. 24L as approximating a point, prongs (2452) may be joined toapproximate any suitable shape that is capable of cutting or puncturingtissue. In some variations, the prongs (2452) may approximate a shapethat functions as a blade.

Additionally, cannula tip (2450) may comprise one or more materials thatmay form a coating over and/or inside of cannula tip (2450). Thiscoating may serve multiple functions. In some instances, the coating maycover any gaps formed between prongs (2452). In other instances, thecoating may reinforce prongs (2452), allowing them to withstand greaterforces applied thereto. In some variations, the coating may be dissolvedor weakened when contacted by one or more liquids or gasses. Inpractice, the coating may be dissolved or weakened once the cannula tip(2450) has served its puncturing function, which may allow the prongs(2452) to be separated and one or more implants to be deployed throughthe cannula tip (2450). Examples of suitable coating materials include,but are not limited to, polyethylene glycol, one or more sugars,chitosan, polycaprolactone, or the like.

In yet other variations, the cannula tip may comprise one or moreslotted tubes. FIGS. 24M and 24N illustrate one variation of cannula tip(2455) comprising slotted tube (2456) having slots (2458) and prongs(2460). Generally, a first end of the slotted tube (2456) may be fixedrelative to the cannula tip (2455), while the second end may be movablerelative to the first end. When the second end is moved relative to thefirst end, one or more prongs (2460) may bend, flex, or deform away fromcannula tip (2455), as shown in FIG. 24N. In some instances, thisexpansion of the slotted tube (2456) may be able to dilate, temporarilyor permanently, one or more tissues or openings. In other situations, anexpanded slotted tube (2456) may be useful in positioning the cannulatip (2455) relative to an opening, as described above.

The shape of the expanded slotted tube (2456) may be dependent on thesize, shape, and orientation of the slots (2458) and prongs (2460), aswell as the manner in which the first end of the slotted tube (2456) ismoved in relation to the second end. As such, slots (2458) and prongs(2460) may have any suitable size shape or orientation. Additionally,while the first and second ends of slotted tube (2456) may be movedtoward or away from each other, they may alternatively be rotated inorder to expand the slotted tube (2456). Indeed, FIG. 24P and FIG. 24Qillustrate one such variation of cannula tip (2462) comprising a slottedtube (2464) having angled slots (2466) and prongs (2468). In thisvariation, rotation of a first end of the slotted tube (2464) relativeto its second end causes the angled prongs (2468) to expand away fromthe slotted tube (2464), as depicted in FIG. 24Q.

Although generally depicted above as having one cannula defining onlyone lumen or aperture, the delivery devices described here may compriseany number of cannulas and each cannula may comprise any number oflumens or other apertures. Indeed, in some variations, the deliverydevices described here comprise two or more cannulas. These cannulas mayor may not be attached to each other. Additionally, the differentcannulas may or may not have the same dimensions, may or may not be madeof the same material, and may or may not have the same number of lumensor other apertures. Any number of cannulas may be steerable, and eachcannula may or may not be independently steerable. Furthermore, thedifferent cannulas may serve the same functions, or may serve differentfunctions. For example, each cannula may be used to deliver one or moreimplants, carry a punch or other tissue piercing device, carry avisualization device or light source, deliver one or more drugs,liquids, gases or a combination thereof, provide suction, carry one ormore steering or shaping elements as described above, carry a dilator orother tissue-expanding device, carry a guide wire, carry a tissue biopsydevice or a tissue ablator, carry one or more devices for lateralizingthe middle turbinate, or a combination thereof.

Where an individual cannula has more than one lumen or aperture, thelumens may have any size shape or configuration. Indeed, FIGS. 25A-25Gillustrate numerous variations of suitable multi-lumen cannulas. In somevariations, one or more lumens may be disposed within one or moreadditional lumens. For example, FIG. 25A depicts a distal end of onevariation of cannula (2500) comprising a first lumen (2502) disposedwithin second lumen (2504). While both first (2502) an second (2504)lumen are shown in FIG. 25A to be circular, each lumen may have anysuitable shape, dimensions, or configuration. Additionally, while shownin FIG. 25A to be concentrically disposed within second lumen (2504),first lumen (2502) may have any suitable location relative to secondlumen (2504).

In other variations, one or more walls may divide a lumen into two ormore separate lumens. FIGS. 25B-25G illustrate several variations ofcannulas that are divided into multiple lumens. FIGS. 25B and 25C depicttwo additional variations where the cannula (2506) is divided into twolumens (2508). Similarly, FIGS. 25D-25F illustrate three variations inwhich the cannula (2510) is divided into three lumens (2512), and FIG.24G depicts a variation of cannula (2514) that has been divided intofour lumens (2516). Each lumen may or may not have the same size, andmay or may not have the same shape. Additionally, each lumen may serveone or more functions, as described above. It is important to note thatthe variations of cannulas shown here are merely illustrativevariations, and any suitable number of lumens having any suitableconfiguration and dimensions may be used without departing from theintended scope of these devices.

The delivery devices described here may have one or more additionalfeatures that may aid in the operation of the delivery device. Forexample, one or more cannulas of a delivery device may be configured torelease one or more drugs or may comprise one or more coatings that areconfigured to release one or more drugs. Any suitable drug orcombination of drugs as described hereinthroughout may be used. In someinstances, one or more drugs having anesthetic or numbing action mayprovide particular utility in minimizing any pain or discomfortassociated with device delivery. In other instances, one or moreantibiotics, antibacterial agents, antifungal agents, antiviral agents,antiseptics or a combination thereof may or may not be useful inpreventing infection that may be associated with device delivery. Instill other variations, the delivery device may comprise one or moreagents that may help maintain homeostasis.

In some variations, the delivery device may comprise one or moredilators attached to or otherwise engaging a cannula. For example, insome variations a balloon or other expandable member may be disposedalong at least a portion of the outer surface of the cannula. Generally,at least a portion of the balloon or expandable member may be expandedaway from the cannula to displace, either permanently or temporarily,one or more tissues near the cannula. The dilator may or may notsurround the cannula, and may or may not be expanded to displace tissuein multiple directions. Additionally, the dilator may be detachable fromthe cannula. This may provide particular utility when it is desirable tokeep a certain pathway open for the duration of the procedure. Forexample, in some instances, the middle turbinate in the sinus anatomymay press against the lateral nasal wall. In order to deliver a deviceinto the ethmoid sinuses, it may be useful to move the middle turbinateaway from the lateral nasal wall. Thus, once a cannula has passedbetween the middle turbinate and the lateral nasal wall, a dilator maybe expanded to further move the middle turbinate away from the nasalwall. Once expanded, the dilator may be disengaged from the cannula. Thedilator may maintain the passage between the middle turbinate and thenasal wall, thereby allowing an operator to remove the delivery devicefrom the nasal passages and reinsert the delivery device without needingto move the middle turbinate each time. The dilator may or may not beconfigured to degrade inside the body, and may or may not be removedfollowing delivery of the one or more implants.

Similarly, the delivery device may comprise one or more implants thatmay be disposed along or otherwise engage an outer surface of a cannula.In some instances, the implant may be an expandable device. In some ofthese variations, the implant may be a self-expanding device, such asthose described above. In others of these variations, the implant may beexpandable as a result of external force applied to the implant.Additionally, the implant may be disposed along or attached to thecannula in any suitable manner. In some variations, a sheath or holdermay hold the implant in place against the cannula. In other variations,one or more coatings may hold the implant in place. In variations wherethe implant is balloon expandable, the implant may be releasably bondedto a balloon. Generally speaking, the implant may be released from thecannula to provide support to one or more tissues. In some variations,the implant may temporarily or permanently dilate one or more tissues,as described just above. The implants may or may not be biodegradable,may or may not be configured to deliver one or more drugs, and may ormay not be removed from the body following the delivery of the one ormore implants.

Additionally, any of the delivery devices described here may compriseone or more sheaths that may be attached to or otherwise engage one ormore cannulas. These sheathes may be made of any suitable material orcombination of materials, and may or may not include any of the cannulatips or features as described above. For example, the cannula maycomprise a funnel-shaped tip, an olive tip, a wedge tip, a slotted tip,a leaf tip, a slotted tube, one or more markers, one or more dilators,one or more stents, or a combination thereof. The one or more sheathsmay be attached to or may engage one or more cannulas in any suitablemanner. For example, in some variations the one or more sheaths may bedisposed along an exterior surface of a cannula. In other variations,the sheath may be disposed inside of one or more cannula lumens.

FIGS. 26A and 26B illustrate a side view and a cross-sectional side viewrespectively of the distal end of one variation of delivery device(2600) comprising a cannula (2602), sheath (2604), and pusher (2606),and which is housing an implant (2608) therein. As shown in FIG. 26,sheath (2604) is configured to have prongs forming a tissue-piercingtip, as described above. In practice, cannula (2602) may be advancedthroughout a portion of the anatomy to a delivery location, and sheath(2604) may penetrate tissue as necessary in advancing delivery device(2600). Once cannula (2602) is in place at the delivery location, sheath(2604) may be withdrawn proximally relative to cannula (2602), and theprongs may open to allow the implant (2608) to pass through the distalend of sheath (2604). The opening of the prongs may or may not be causedby engagement between the sheath (2604) and the pusher (2606). Note thatalthough sheath (2604) is shown in FIG. 26 to reside between cannula(2602) and pusher (2606), sheath (2604) may instead be disposed aroundthe outside of cannula (2602).

In some variations, the delivery device may be configured to release thesheath. In some of these variations, the sheath may be released insideof the body. In some instances, the sheath may be configured to be heldin one or more portions of the body. For example, in variations wherethe sheath comprises a slotted tip, the prongs of the slotted tip may beexpanded inside of the body. Once expanded, the prongs may resistmovement through an opening such as a sinus ostium, and the sheath maybe held substantially in place. The sheath may or may not be configuredto degrade, and may or may not be configured to release one or moredrugs. Additionally, in some instances the sheath may be used as a tubethrough which one or more liquids or gases may be passed into the body.

Pusher

In variations of the delivery devices described here that comprise apusher, such as those shown in FIGS. 5A and 5B, the pusher may have anysuitable size, shape, and configuration. Additionally, the deliverydevice may comprise any number of pushers. Each cannula or cannula lumenmay comprise one or more pushers slidably disposed therein.Additionally, each pusher may or may not comprise one or more lumenstherethrough, and may or may allow a liquid or gas to pass therethrough.FIG. 27 shows one variation of pusher (2700) comprising body (2702) andhead (2704), and disposed within cannula (2706). Generally, pusher(2700) may be advanced relative to cannula (2706), and head (2704) mayengage one or more implants (2708) to push the one or more implants(2708) out of the distal end of the cannula (2706). Body (2702) and head(2704) may or may not be made of the same material, and may or may nothave the same width. In some instances, it may be desirable to maintaina certain ratio between the diameter of the cannula (c) and the diameterof the pusher (p). For example, the ratio of the diameter of the cannulato that of the pusher, or c:p, may be about 10:1, about 9:1, about 8:1,about 7:1, about 6:1, about 5:1, about 4:1, about 3:1, about 2:1, andthe like. Indeed, certain ratios may allow delivery device to have asubstantially rigid pusher body (2702) and a curved cannula (2706)without the pusher body (2702) substantially affecting the shape of thecannula (2706).

In some variations, the pusher may comprise one or more features thatmay aid in loading one or more implants into a cannula. FIGS. 28A and28B illustrate one such variation of pusher (2800) comprising body(2802) and head (2804) including runners (2806). Generally, head (2804)and runners (2806) may fit within cannula (2808), as shown in FIG. 28A.When pusher (2800) is advanced and runners (2806) exit cannula (2808),the runners (2806) may or may not bend, flex, or rotate away from eachother, as shown in FIG. 28B. To help load an implant into the cannula(2808), pusher (2800) may first be advanced such that runners (2806)exit cannula (2808), the implant may be positioned inside the aperturedefined by runners (2806), and the pusher (2800) may be withdrawn intothe cannula (2808). As the runners are pulled back into the cannula(2808), the cannula (2808) may cause the runners (2806) to return totheir original positions, and may thereby grasp or grab the implant. Asthe pusher (2800) continues to be proximally withdrawn, the runners(2806) may pull the implant inside of cannula (2808).

While described above as comprising a pusher, the delivery devicesdescribed here need not have a pusher. Indeed any suitable actuationmechanism may be used. For example, delivery may be actuated by theintroduction of one or more gasses or liquids to the cannula (e.g.pressurized air, inert gases, water, saline, or the like). In othervariations, a stopper may be used to help release one or more implants.FIGS. 29A and 29B illustrate one variation of delivery device (2900)comprising stopper (2902). Shown in FIG. 29A is stopper (2902)comprising holding segment (2904) and head (2906), and disposed withincannula (2908). Generally, one or more implants (not shown) are housedwithin cannula (2908) in the holding segment (2904) or stopper (2902),and head (2906) prevents the one or more implants from being prematurelyreleased from the cannula (2908). Indeed, to release the one or moreimplants, cannula (2908) may be withdrawn relative to stopper (2902) orstopper (2902) may be advanced relative to cannula (2908) to exposeholding segment (2904) and the one or more implants, as shown in FIG.29B.

While shown in FIGS. 29A and 29B as having a narrower diameter than therest of stopper (2902), holding segment (2904) may have any suitablesize, shape or configuration. Indeed, in some variations holding segment(2904) may comprise one or more channels passing at least partiallythrough the stopper (2902). Additionally, the one or more implants mayor may not be releasably attached to the stopper (2902).

Generally, delivery devices comprising a stopper may provide the usergreater leeway in controlling the placement of the one or more implants.Indeed, in variations where an implant is pushed out the distal end of adevice, it may be difficult to ensure proper placement relative to oneor more structures. In variations with a stopper, the distal end of thedelivery device may be placed in approximation with one or more tissuestructures. By withdrawing the cannula relative to the stopper, theholding structure may be exposed to release the one or more implants.This may provide utility in allowing a user to place an implant inproximity with one or more tissue structures.

FIGS. 30A-30F show another variation of delivery device (3000)comprising a stopper (3002). FIG. 30A depicts a perspective view ofdelivery device (3000). Also shown there is stopper (3002) comprisingholding portion (3004) and restraining member (3006), and cannula (3008)comprising cannula aperture (3010). FIG. 30B shows a side view ofstopper (3002), and FIG. 30C shows a side view of cannula (3008).Generally, stopper (3002) is configured to house one or more implants inholding portion (3004), which defines stopper aperture (3012), and mayrelease the one or more implants therethrough. Additionally, restrainingmember (3006) may or may not be slidably disposed within stopper (3002),and may or may not be able to releasably connect one or more implants tostopper (3002). For example, in variations where delivery device (3000)is used to deliver an implant that defines a lumen or aperture,restraining member (3006) may be passed through this lumen or aperture,thereby preventing the implant from being disengaged from the deliverydevice (3002). It is important to note that while shown in FIGS. 30A-30Fas having a restraining member (3006), stopper (3002) need not.

In practice, one or more implants may be placed in holding portion(3004), and stopper (3002) may be placed within cannula (3008). Stopper(3002) may or may not be configured to rotate within cannula (3008). Invariations where stopper (3002) is able to rotate within cannula (3008),rotation of the stopper (3002) or cannula (3008) may be used to releasethe one or more implants. When the stopper (3002) is placed withincannula (3008), the delivery device may have an open configuration and aclosed configuration, depending on whether cannula (3010) and stopper(3012) apertures are aligned. When the apertures are not aligned,delivery device (3000) is “closed” as the stopper aperture (3012) iscovered by the body of cannula (3008), as shown in a top view in FIG.30D. To open the device, a user may rotate the cannula (3008) or stopper(3002) to align the apertures. At this point, one or more implants maybe released from the delivery device (3000) through the apertures.

In variations that include a restraining member (3006), however, therelease of the one or more implants may require an additional step.Assuming that the restraining member (3006) has been configured toreleasably attach the implant to the delivery device (3000), therestraining member (3006) may need to be withdrawn, as shown in a topview in FIG. 30F, before the implant may be released. A restrainingmember (3006) may provide a user with additional control in properlyplacing a self-expanding device (not shown), such as those describedabove. When a delivery device (3000) holding a self-expanding device ismoved from a closed to an open configuration, the self-expanding devicemay have a tendency to expand through the cannula aperture (3010), butis still at least partially attached to the delivery device (3000) byrestraining member (3006). Were it not for this attachment, theself-expanding device may be completely released from the device,thereby making it difficult to reposition the self-expanding device onceit has already been expanded. Instead, the attachment may allow a userto reposition the expanded self-expanding device as necessary. Once theself-expanding device has been properly placed, a user may retract therestraining member (3006) to release the self-expanding device.

While shown in FIG. 30C as having cannula aperture (3010), cannula(3008) need not. Indeed, in some variations the same effect may beachieved by withdrawing cannula (3008) relative to stopper (3002) or byadvancing stopper (3002) relative to cannula (3008). In thesevariations, as cannula (3008) is withdrawn or stopper (3002) is advancedsuch that stopper aperture (3012) is exposed, the delivery device (3000)may release one or more implants. As mentioned above, the restrainingmember (3006) may limit or control the release of the one or moreimplants.

FIGS. 31A-31C depict cross-sections of additional illustrative distalportions of delivery device configurations. FIG. 31A provides across-sectional representation of one variation of the distal end ofsuitable delivery device (3120). Shown in this variation is cannula(3122), guide wire or guide element (3124), and expandable balloon(3126). In this variation, device (3128) is placed in its compressedconfiguration around expandable balloon (3126). Once the delivery devicehas been advanced to the desirable target location, the cannula (3122)may be withdrawn proximally, or the guide wire (3124) may be advanceddistally, to expose the balloon (3126) and device (3128) to the targettissue. The balloon may then be expanded to help the device betterappose the target tissue. In some variations, the balloon may be heatedto aid in device expansion or deformation. Once device (3128) has beendeployed, expandable balloon (3126) may be deflated and delivery device(3120) may be withdrawn, leaving the expanded device (3128) at thetarget location.

Of course, while shown in FIG. 31A as an expandable balloon (3126), itshould be understood that any expandable structure may be used. Theexpandable structure may be made from any suitable material, such as,for example, latex, polyamide, nylon, polyethylene, low-densitypolyethylene, Duralyn®, Duramax®, Pebax®, polyurethane, and any analogs,homologues, congeners, derivatives, salts, copolymers, and mixturesthereof.

FIG. 31B shows another variation of the distal end of delivery device(3130). This variation is similar to the variation described just abovewith reference to FIG. 31A, except that no balloon is used. Shown inthis variation, is cannula (3132), guide wire or guide element (3134),and device (3136) disposed about guide wire (3134). In use, once thedelivery device is advanced to or adjacent to the target location, thecannula (3132) may be proximally withdrawn, or the guide wire (3134) maybe advanced distally to position device (3136) at the desired location.The guide wire (3134) may then be withdrawn, leaving device (3136) toself-expand.

FIG. 31C depicts yet another variation of the distal end of a deliverydevice (3140). In this variation the delivery device (3140) comprises aguide wire (3142) having a distal tip (3144), around which device (3146)is disposed. The device (3146) is releasably attached to a suture (3148)or other similar such material, the ends of which, are run through asuture sheath (3150). In this variation, the delivery device (3140) maybe advanced to a target location and suture (3148) withdrawn proximallythrough the suture sheath (3150), thus releasing the device (3146) andallowing it to self-expand. It should be understood that the abovedescribed variations, are but a few of the many possible variations thatmay be suitable for the delivery devices described here.

FIGS. 32A and 32B illustrate still another variation of delivery device(3200) comprising cannula (3202) having cannula aperture (3204) andsheath (3206) comprising sheath aperture (3208). While shown in FIG. 32Aas being disposed on cannula (3202), sheath (3206) may be located withincannula (3202), and may be configured in any way with any feature orcombination of features as described above. Cannula (3202) and sheath(3206) may or may not be able to rotate relative to one or another, ormay or may not be able to slide relative to one another. The deliverydevice (3200) may have an open configuration and a closed configuration.In the closed configuration, the cannula aperture (3204) is covered by aportion of the sheath (3206), and the sheath aperture (3208) is blockedby a portion of the cannula (3202), as shown in a side view in FIG. 32A.To release one or more implants from delivery device (3200), cannula(3202) and sheath (3206) may be moved, whether through rotation orsliding actuation, such that at least a portion of cannula aperture(3204) and sheath aperture (3204) overlap, as shown in a side view inFIG. 32B. When the cannula (3204) and sheath (3208) apertures overlap, adevice may pass through the apertures to exit delivery device (3200).

Handle

The delivery device's handle may have any suitable dimensions orconfiguration of elements, and may include any suitable manner ofactuating the device. Indeed, each handle may have any suitable numberof buttons, knobs, triggers, cranks, levers or other actuatingcomponents for actuating one or more of the features of the deliverydevices, as described above. Each actuating component may control one ormore feature of the device, or may control multiple featuressimultaneously. For example, in variations where the device comprisestwo control lines for steering a cannula, each control line may becontrolled by a separate actuating component, or both may be controlledby the same actuating component. For example, the handle may comprise aknob that affects the amount of tension placed on each control line.When the knob is rotated in one direction, the tension may be increasedin a first line and decreased in second line, and vice versa when theknob is rotated in the other direction.

In variations where the handle comprises a pusher or a stopper asdescribed above, the handle may be configured to actuate the pusher orstopper in any suitable manner. In some variations, the handle may beconfigured to advance a pusher or stopper relative to the cannula. Forexample, in the variation shown in FIG. 5B above, handle body (516) isattached to cannula (514), while plunger (520) is attached to pusher(522). Thus, when the plunger (520) is pushed relative to handle body(516), pusher (522) is advanced relative to cannula (514). In othervariations, the handle may be configured to retract a cannula relativeto a pusher or stopper. FIG. 33 shows a variation of delivery device(3300) comprising handle (3302), stopper (3304) and cannula (3306). Asshown in FIG. 33, handle (3304) comprises grip (3308) and trigger (3310)attached to body (3312). In this variation, cannula (3306) may beconnected, permanently or releasably, to body (3312), and stopper (3304)may be attached to grip (3308). To release an implant from deliverydevice (3300), an operator may hold grip (3308) and pull trigger (3310)proximally relative to grip (3308). As the trigger (3310) movesproximally, cannula (3306) moves proximally, thereby withdrawing cannula(3306) relative to stopper (3304).

In variations that include a pusher or a stopper, the handle may beadjustable to control the amount of movement of the pusher, stopper, orcannula when a trigger is activated. FIG. 34A shows a cross sectionalview of one variation of handle (3400), while FIGS. 34B-34D illustratesuitable variations of adjustable handles. Shown in FIG. 34A is handle(3400) comprising handle body (3402), spring (3404), pusher (3406),plunger (3408) and connector (3410). Generally, handle body (3402)houses spring (3404) and connector (3410), such that spring (3404)biases connector (3410) away from the proximal end of the handle body(3402). Additionally, connector (3410) may connect plunger (3408) andpusher (3406). To activate the device, a user may depress plunger(3408), advancing pusher (3406) and compressing spring (3404). When theplunger (3408) is no longer being depressed, spring (3404) may pressagainst connector (3410) to return the handle to its pre-activationconfiguration.

FIG. 34B illustrates one variation of handle (3412) comprising anadjustable ring (3414). The remaining components of handle (3412) areotherwise the same as shown in FIG. 34B and are labeled as such.Adjustable ring (3414) may be releasably attached to a portion ofplunger (3408), and may limit the amount that plunger (3408) may bedepressed. This may find particular utility when cannulas of differentlengths are used with the same handle (3412). For each cannula, anoperator may adjust the adjustable ring (3414) to provide the properranger of movement for plunger (3408) and pusher (3406).

FIGS. 34C and 34D illustrate variations of adjustable handles in whichone or more components may have threading. FIG. 34C illustrates avariation of delivery device (3416) in which trigger (3408) hasthreading (3418) that corresponds to tracks (3420) within a hollowportion (3422) of connector (3410). To adjust the length of trigger(3408) and thereby the amount that trigger (3408) may be depressed,trigger (3408) may be rotated to screw a portion of trigger (3408) intothe hollow portion (3422) of connector (3410). Similarly, 34Dillustrates a variation of delivery device (3424) in which pusher (3406)comprises threading (3426) that may be screwed into tracks (3428) inhollow portion (3430) of connector (3410). This may adjust the relativelength of pusher (3406).

II. Methods of Use

Both the self-expanding devices and the delivery devices described heremay be useful in a variety of locations within the body, for a number ofdifferent purposes. For example, the self-expanding devices may helpprovide support to or dilate tissue, or may be useful in treatingvarious conditions or diseases. The self-expanding devices may indeed beused in any area of the body that may benefit from their structural andfunctional features.

For example, the devices may be delivered to one or more tonsils, sinuscavities, arteries, veins, one or more openings or cavities, e.g., themiddle ear or tympanic cavity, hollow-body organs such as the ureter,fallopian tubes, biliary ducts; pulmonary organs such as tracheas,bronchi and bronchioles; and gastrointestinal organs such as theesophagus, stomach, intestines, and colon, and the like. In the case ofsinuses, the devices may be used before or after surgery. In somevariations, the devices described here are used in the sinus cavities ofpediatric patients. This may be particularly advantageous compared totraditional treatment options for pediatric patients in that in usingthe described devices and methods the risk of poor patient compliance isreduced.

The devices can further be used to treat and/or ameliorate one or moresymptoms of a variety of diseases that include, but are not limited to,urinary incontinence, atherosclerosis, benign prostatic hypertrophy,recoiling lesions after percutaneous transluminal angioplasty and indissections, chronic occlusions, anastamotic hyperplasia in vein graftsand synthetic vascular grafts, vulnerable plaque, aneurysms of the aortaand large arteries, arteriovenous fistulae and traumatic leaks,malignant stenosis of the gastrointestinal tract, acute ileus incolorectal cancer, biliary closure from cholangiocarcinoma or otherhepatic cancers, benign compression of the trachea and malignanttracheobronchial obstructions, one or more diseases or conditions of thesinuses, and the like.

The devices may be delivered and deployed in any suitable manner. Insome variations, the devices are deployed in an open surgical fashion.In other variations, the devices are deployed in a less invasive fashion(for example, laproscopically, endoscopically, or intravascularlythrough the use of catheters). In instances where the devices aredelivered in a generally minimally invasive fashion, the devices aredelivered in their compressed configurations. The devices may bepreloaded in a delivery device, but need not be. For example, ininstances where the device has a limited ability to fully expand afterremaining in its compressed state for extended periods of time (i.e.,relaxation of the device may occur over time, resulting in a loss ofshape memory, for example), it may be more desirable to crimp and loadthe device into a delivery device just prior to delivery and deployment.The device may be crimped straight into a delivery device.

While additional methods of crimping the devices described here will bediscussed in detail below with specific reference to the methods ofmanufacture, FIGS. 4A-4C illustrate one possible method by which device(400) may be reduced into its compressed configuration using a suture(402), fiber, or other similar material, and then placed in a lumen(404) of a delivery device (406). In variations of a device (400) havingmultiple loops (408), the suture (402) may be threaded through all orsome of the loops, and may be threaded through the loops one or moretimes while the device (400) is in its expanded configuration. Once thesuture (402) is threaded through a desirable number of loops, the endsof the suture (402) may be pulled to reduce device (400) into itscompressed configuration, as shown in FIG. 4B. In some variations, theends of the suture (402) are pulled in the same direction, and in othervariations, they are pulled in opposite directions. In still othervariations, the ends of the suture may be pulled at different angles. Asdepicted in FIG. 4C, the suture (402) may then be removed and discarded,and the compressed device (400) may be loaded into the lumen (404) of adelivery device (406) via its distal end (or proximal end as the casemay be). The suture may be removed before or after the device is loadedwithin the lumen, and as described above, the suture (402) may also beleft threaded through the loops (408), in the event retrieval orwithdrawal of the device is desirable.

Other methods may also be used to reduce the device (400) to itscompressed configuration. For example, the device may be manuallycompressed using one's fingers, or placed within a cylindrical devicethat is capable of reducing its diameter. The device may even bemanufactured in its compressed configuration, and then later be manuallyor thermally expanded or deformed into its expanded configuration.

In another method, the device may be placed on a tapered mandrel, andslid down the mandrel, reducing the diameter of the device. An outersheath or funnel may be placed over the tapered mandrel in order tocontrol the outer diameter of the device. The end of the tapered mandrelmay then be placed within a delivery device, and the outer sheath/funnelmay be removed, thereby leaving the device in its compressedconfiguration within the delivery device.

In yet another method, the device may be placed in the opening of afunnel. A fiber attached to the device may be withdrawn through thefunnel, pulling the device and crimping it as its diameter is reduced.Similarly, a balloon may be placed within the funnel, at least partiallyexpanded, and pulled through the funnel to crimp the device. Such aballoon may provide for uniform crimping due to the friction forcebetween the device and balloon.

In still other methods, a roll crimper is used to reduce the device toits compressed configuration. In these methods, the device is first slidloosely onto the balloon portion of a guide wire. This assembly isplaced between the plates of the roll crimper. With an automated rollcrimper, the plates come together and apply a specified amount of force.The plates move back and forth a set distance in a direction that isperpendicular to the guide wire. The guide wire rolls back and forthunder this motion, and the diameter of the device is reduced. Theprocess can be broken down into more than one step, each with its ownlevel of force, translational distance, and number of cycles.

Still other methods utilize a sliding wedge or iris crimper to reducethe device to its reduced configuration. In the sliding wedge or iriscrimper, adjacent pie-piece-shaped sections move inward and twist, muchlike the leaves in a camera aperture. This crimper can be engineered tohave two different types of endpoints. It can stop at a final diameter,or it can apply a fixed force and allow the final diameter to float. Thesliding wedge crimper presents a nearly cylindrical inner surface to thedevice, even as it crimps. This means the crimping loads are distributedover the entire outer surface of the device. Additionally, theself-expanding devices may be crimped using any of the methods ordevices described in U.S. Provisional Application Ser. No. 61/085,795,titled “Methods and Devices for Crimping Self-Expanding Devices,” whichis hereby incorporated by reference in its entirety.

Any of the delivery devices described above may be used to deploy theself-expanding devices described here, as well as any other suitableimplant or implants. Generally, the distal end of a delivery device isintroduced into the body. In some variations, the distal end of thedelivery device may be introduced into a natural opening in the body,such as an ear canal or a nostril. In other variations, the distal endof the delivery device may be introduced into an artificially-createdopening in the body. In some of these variations, theartificially-created opening may be preformed using one or more toolsthat are separate from the delivery device. In variations where thedelivery device has a cannula or sheath configured to puncture tissue orotherwise carries one or more tissue-piercing devices, the deliverydevice may be used to create the opening.

Once the delivery device has gained access to the body, at least aportion of the delivery device, which may be a portion of one or morecannulas, may then be advanced to a target location. In some variations,this advancement occurs under direct visualization. The directvisualization may be achieved by a device external to the deliverydevice, such as an endoscope, or may be achieved by one or morevisualization devices disposed in one or more lumens of a cannula or byone or more visualization devices attached to the delivery device. Inother variations, the advancement occurs under indirect visualization,such as fluoroscopy or ultrasound.

During advancement, it may be desirable to provide an anesthetic orother numbing drug to help minimize pain associated with the procedure.In some variations, the delivery device may spray or eject one or morefluids or gases that comprise one or more drugs. In other variations, aportion of the delivery device, such as a cannula, may release one ormore drugs, or may comprise a coating that releases one or more drugs.

Additionally, during advancement of the delivery device it may benecessary to displace, either temporarily or permanently, one or moretissues. In some variations, one or more cannulas or sheathes of thedelivery device may comprise a tip, as described above, that may be usedto displace one or more tissues. Additionally, one or more dilators oradditional implants may be used to either temporarily or permanentlydilate one or more tissues, and may be used to maintain an openpassageway between the body opening and the target location. In stillother variations, one or more dilators separate from the delivery devicemay be used to either temporarily or permanently dilate or otherwisedisplace one or more tissues. The one or more dilators may displacetissue before advancement of the delivery device, or may displace tissuesimultaneously with advancement of the delivery device. Additionally,the one or more dilators may or may not sequentially dilate the tissue(e.g. by introducing dilators of increasing size, or sequentiallyincreasing the size of the dilator).

Once the delivery device has reached the target location, the tip of acannula or sheath may be positioned relative to one or more tissues ortissue openings. Once the tip is properly positioned, the deliverydevice may release or otherwise eject the one or more self-expandingdevices or other implants. In some variations, the released device ordevices may be repositioned as necessary.

In some variations, the devices are sized and shaped to be deliveredwithin one or more sinus cavities, or one or more locations where asinus cavity has been removed. Any of the devices and methods describedhere may also be used to treat one or more locations of the osteomeatalcomplex as described in U.S. patent application Ser. No. 11/775,157filed on Jul. 9, 2007, which is hereby incorporated by reference in itsentirety. FIG. 6 shows a simplified depiction of the anatomy of thesinuses following a typical sinus surgery. Shown there is maxillarysinus (600) having a surgically-enlarged maxillary sinus opening (602),surgically enlarged ethmoid sinus (604), and nasal cavity (606). Itshould be understood that while the methods described just below will bein reference to device delivery and deployment to one or more sinuscavities following a typical sinus surgery, any of the devices describedherein may also be delivered to one or more sinus cavities prior to atypical sinus surgery.

Deploying one or more of the devices described here to one or more ofthe sinus cavities may help maintain the patency of the sinus cavities,help prevent obstruction caused by adhesions between healing or inflamedmucosal surfaces, and help deliver an effective localized dose of adrug. When placed in the ethmoid sinus following sinus surgery, a devicemay help prevent lateralization of the middle turbinate, which couldotherwise lead to formation of adhesions that may block the sinusopening. In addition, the devices described here may aid in the naturalhealing process when they are configured to deliver one or more drugs toone or more sinus cavities after a sinus surgery. In addition, when adevice that defines a lumen (having any suitable cross-sectionalgeometry) in its expanding configuration is used (e.g., the device shownin FIG. 1A), the device may offer the additional benefit of providingbetter access to the surgical site for post surgical clean-up andfollow-up. That is, as opposed to traditional packing materials, adevice defining a lumen allows for more natural clearance of mucus andsinus drainage, and allows for easier irrigation and removal of otherdebris.

FIGS. 7A-7C illustrate a method of delivering a device (704) to anethmoid sinus (700) using a delivery device (702). With reference now toFIG. 7A, the delivery device (702) is first advanced through nasalcavity (706) (e.g., under endoscopic guidance), and into ethmoid sinus(700). Once the delivery device (702) reaches the desirable locationwithin the ethmoid sinus (700), as shown in FIG. 7B, the device (704)may be deployed. Once the device (704) is fully deployed (i.e., itchanges into its expanded configuration), as depicted in FIG. 7C, thedelivery device (702) may then be removed from the body. Althoughdepicted in FIGS. 7A-7C as a delivery cannula or other introducer devicewith a push rod (not shown), the delivery device (702) may be any devicesuitable to deploy a device (704), as described above.

FIGS. 8A-8C illustrate a method of delivering device (804) to amaxillary sinus (800) using a delivery device (802). With reference nowto FIG. 8A, the delivery device (802) is first advanced through nasalcavity (806) (e.g., under endoscopic guidance), and into maxillary sinus(800). Once the delivery device (802) reaches the desired location withthe maxillary sinus (800), as shown in FIG. 8B, the device (804) may bedeployed. Once the device (804) is fully deployed (i.e., it changes intoits expanded configuration), as depicted in FIG. 8C, the delivery device(802) may then be removed from the body. Although depicted in FIGS.8A-8C as a delivery cannula or other introducer device with a push rod(not shown), the delivery device (802) may be any device suitable todeploy a device (804), as described above.

As described above, the devices may be repositioned during or afterdelivery, if desirable. Similarly, the devices may be removed (either bya suture or other similar such material, by gripping the device withforceps or the like, or via suction or aspiration, etc.).

While shown in FIGS. 7A-7C and 8A-8C as being delivered to the ethmoidand maxillary sinuses, respectively, it should be clear that the devicesmay be delivered to any of the sinus cavities. For example, the devicesmay be delivered to a frontal sinus or a sphenoid sinus. Similarly, thedevices may be delivered into the nasal passage or the ostium of anysinus cavity. The devices may be deployed anywhere, and may or may notbe configured to deliver a drug.

FIGS. 9A-9C depict a method of delivering a device (904) within one ormore vessels within the vasculature. As shown in FIG. 9A, deliverydevice (900) is first introduced into the body (e.g., through thefemoral or jugular arteries, or via any other suitable known accessroute), and then advanced through the vasculature to a target location.In the variation shown in FIG. 9A, the delivery device comprises anexpandable balloon (902) having a device (904) disposed thereon. Ofcourse, the delivery device need not be so configured, as any suitabledelivery device may be used.

Once delivery device (900) has been advanced positioned at the desiredlocation, the cannula may be withdrawn proximally or the balloon (902)advanced distally, to expose the device (904) to the target location, asshown in FIG. 9B. The balloon may then be expanded, and the device (904)deployed. Once fully expanded, as shown in FIG. 9C, the delivery device(900) may then be removed. The devices may be placed in veins orarteries, at locations of plaque formation (e.g., vulnerable plaqueformation), or at locations of potential plaque formation. In addition,the devices may have a configuration that would be particularlydesirable or suitable for use at a bifurcated vessel section.

With respect to use within the vasculature, the devices described heremay have particular applicability in conjunction with treatingthin-capped fibroatheromas (TCFAs), or other types of plaques. TCFAs area class of plaques that, if ruptured, can cause rapid lumen occlusionand heart attack. The plaques have a number of structural features thatmake them more difficult to treat than stable lesions. By providing adevice capable of releasing tissue-adhesion-promoting molecules to aTCFA, it may be possible to stabilize and strengthen the TFCA's cap,which in turn may allow the TCFA to receive treatment as if it were astable lesion. Since TFCA's are susceptible to cap rupture, the devicesmay be made from a material that opens or may be opened in a slow,controlled manner. Additionally, in some variations, it may be desirableto release one or more pro-healing drugs to the TCFA.

FIGS. 10A-10C illustrate one method of using the devices described hereto shunt urine around a blockage (1000) of a ureter (1002). As shown inFIG. 10A, delivery device (1004) is advanced to a location between thewall of ureter (1002) and obstruction (1000). Once delivery device(1004) is positioned at a desirable location, as illustrated in FIG.10B, device (1006) may then be deployed. When deployed, device (1006)creates a channel in ureter (1002) through which urine can pass, therebybypassing the blockage (1000) as depicted in FIG. 10C. The deliverydevice (1004) may then be withdrawn.

The devices described here may also be used to treat urinaryincontinence. For example, the devices may be placed in the bladderand/or the urethra to prevent obstruction of the urinary passageway by agrowing prostrate or other circumstance. Drugs that may be useful in thetreatment of urinary incontinence include, but are not limited to,alpha-blockers, imiprapine, antispasmodics, and 5-alpha reductaseinhibitors.

III. Methods of Manufacture

The devices described herein may be made in any suitable manner. Ingeneral, the method comprises producing a polymer filament and formingthe filament into the device. The method may optionally comprise coatingthe polymer filament with a drug eluting layer, doping the filament withdrug depots, or the like. Additional steps may include heat setting andquenching the device, packaging the device, and sterilizing the device.These steps may be implemented in any appropriate order, and each stepor combination of steps may be removed or replaced with other steps asnecessary or appropriate.

The polymer filament may be produced by any suitable method. Methods ofproducing a polymer filament include, but are not limited to, extrusionmolding, wet spinning, dry spinning, gel spinning, laser cutting andinjection molding. In methods that use injection molding, thefully-formed device may be produced using injection molding. In methodsthat use extrusion molding, suitable polymers may be extruded using amelt phase process to form a polymer of a certain diameter. In thesemethods, the polymer will be brought to a temperature above the polymermelting temperature. At this point, the melted polymer or polymers arethen pushed or drawn through a die to form the filament. This filamentmay be further drawn down to a smaller diameter in order to orient thepolymer molecules. The drawing ratio may be any suitable ratio, forexample 6.

When a drug eluting layer or drug depot is desired, a coatingformulation (which may form the layer or depot) may be prepared. Thiscoating formulation may be created by mixing a combination of degradablepolymers, release-rate modifiers and drug components. The coatingformulation may be configured to have a specific viscosity, depending onwhat process will be used to coat the filament. Since the drug deliveryprofile may partly depend on the viscosity, the coating formulation mayhave a viscosity that is suitable both for coating and for drugdelivery.

Once the filament has been created and the coating formulation has beenprepared, the filament may then be coated with the coating formulationto create a drug-eluting layer. In some variations, the filament isfirst plasma cleaned in order to improve adhesion of the coatingformulation to the filament. The coating process may be any suitableprocess, including, but not limited to, spraying, misting, atomizing,dipping, brushing, pouring, dripping, spinning, roller coating, meniscuscoating, powder coating and inking procedures. In some variations, thefilament is formed into its final configuration prior to coating. Inthese variations, a coating fixture may be used to hold the deviceduring the coating process. In some of these variations, the coatingfixture may hold the formed filament by its apex, to allow for sprayingor dipping without depositing the coating formulation on the coatingfixture. In device variations that include loops, the loops may be usedto secure the device to the coating fixture.

In some variations, a spray coating process is used where the spraycoating follows or traces the device pattern. In these variations, thedevice is rotated and moved backwards and forwards under the spray headto trace the device pattern. Tracing the device patterns in such amanner may result in a transfer efficiency of as much as 20%, where thetypical efficiency for device spray coaters is about 5%. In thesevariations, device loops may be used to provide the proper orientationfor the device when placed on the coating fixture. Furthermore, in thesevariations, the coating fixture may include a spring that provides axialstress, thereby allowing the device to maintain its shape.

For devices that contain multiple drug eluting layers, a multi-coatingprocess may be used to form the different layers. In one variation of amulti-coating process, the device filament may be run through a coatingbath or a micro-pump that deposits a first coating on the devicefilament, which then passes through a heating or ultraviolet element inorder to cure the layer. The device filament may then be run throughadditional depositing and curing elements in order to form additionallayers.

The device filament may then be manipulated into a device configurationby any suitable method. In some variations, a formation fixture is usedto determine the final shape of the device. In these variations,constant tension may be applied to the device filament as it is woundaround the formation fixture into its final configuration. In doing so,the percent strain of the device filament may be controlled.Additionally, by winding the device filament around struts strategicallylocated on the formation fixture, loops may be formed on the device. Inother variations, the formation fixture is flat, and the device musteventually be manipulated into its final configuration.

Once the device filament is placed in its final configuration on theformation fixture or otherwise, the ends of the filament may be bondedto create a continuous filament loop. In some variations, this bondingis achieved by a biodegradable polymer glue in an appropriate solvent,and this polymer glue may be the same polymer as the coating polymer. Invariations including polymer filaments, the solvent for the polymer glueis generally a non-solvent for the polymer filament. In othervariations, the bonding may be achieved by heat welding, laser welding,ultrasonic welding, or RF welding of the device filament ends.

Once the device has been formed, it may be heat set. The device isgenerally heat set under tension, and any suitable heating parametersmay be utilized, for example, heating at 120° C. for 10 minutes. Invariations utilizing a polymer filament, the device may be heated at atemperature between the polymer filament glass temperature and itsmelting temperature. Once the device has been heated, it may then bequenched. Any suitable quenching parameters may be used, for example,cooling at −20° C. for 10 minutes. In variations utilizing a polymerfilament, the device may be quenched at a temperature below the glasstemperature of the polymer filament.

Once the device has been formed, heated, and quenched, drug depots maybe added or filled with a drug. The device may be weighed at multipletimes during this process, in order to determine the amount of drugadded. Once the device has been completed, it may then be inspected,packaged and sterilized by any suitable processes. In some methods, thedevice may be packaged with a support to support and maintain the deviceform during sterilization and/or shipping. Similarly, a suture orfilamentous material may be used to prevent the device from changingshape during these steps. Sterilization may utilize any suitableprocess, including, but not limited to, gamma sterilization and E-beamsterilization.

FIG. 11 provides a flow chart illustrating one method of manufacturingthe devices described herein in accordance with the techniques describedjust above. However, the devices may be formed from a number ofalternate methods. In some variations, the device is cut from a film,e.g., a rolled cylinder. Alternatively, the device pattern may be cutfrom the film, and then rolled into a cylinder. In other processes, thedevice may be formed by bonding together smaller non-intersectingfilament segments. In these variations any of the bonding methodsmentioned above may be used to join the filament segments.

In still other variations, the device may be formed by compression,injection, or foam molding. In compression molding, solid polymericmaterials are added to a mold, then pressure and heat are applied untilthe polymeric material conforms to the mold. The solid form may requireadditional processing to obtain the final product in a desired form. Ininjection molding, solid polymeric materials are added to a heatedcylinder, softened and forced into a mold under pressure to create asolid form. The solid form may require additional processing to obtainthe final product in a desired form. In foam molding, blowing agents areused to expand and mold solid polymeric materials into a desired form,and the solid polymeric materials can be expanded to a volume rangingfrom about two to about 50 times their original volume. The polymericmaterial can be pre-expanded using steam and air and then formed in amold with additional steam; or mixed with a gas to form a polymer/gasmixture that is forced into a mold of lower pressure. The solid form mayrequire additional processing to obtain the final product in a desiredform.

IV. Examples Device Preparation

A poly(L-lactide-co-glycolide) polymer filament with a lactide toglycolide ratio of about 10:90 was prepared by extruding the polymerusing a melt phase process. The fiber was then drawn down with a drawingratio of approximately 6, resulting in a diameter of about 0.36 mm. Theresulting filament had a tensile strength of approximately 580 MPa, aYoung's modulus of approximately 7400 MPa and a strain to failurebetween 50% and 60%. These values were determined using an Instrontensile test with a strain rate of 25 mm/min at room temperature.

A crown-shaped device, as described above and depicted in FIGS. 1A andB, was formed using the polymer filament, and was coated with a drugeluting layer. The device was further able to be reduced from anexpanded configuration diameter of approximately 5 cm to a reducedprofile diameter of about 4.5 mm. The expanded device was able toprovide support to an area up to about 23.5 cm². The device was thensterilized using a 28±10% kGy e-beam sterilization dose. The sterilizeddevice had an inherent viscosity of about 1.0 dL/g in HFIP at 25° C., asdetermined by a size 75 Cannon-Ubbelohde viscometer.

Mechanical Strength Testing

The mechanical strength of one variation of the devices described hereas a function of time was tested. A number of crown-shaped devices, asdescribed above, were made with a poly(L-lactide-co-glycolide) devicefilament with a lactide to glycolide ratio of about 10:90. A drugeluting coating was formed with approximately 6000 molecular weightpolyethylene glycol, mometasone furoate, acetone andpoly(DL-lactide-co-glycolide) with a lactide to glycolide ratio of about70:30. The devices were packaged in pouches composed of a Foil/PElaminate, and were sterilized using E-beams with a total dose of 28kGy±10%. The devices were removed from their packaging and stored withSepragel (Genzyme Biosurgery, Cambridge, Mass.) and Meropack(MedtronicENT, Inc., Jacksonville, Fla.) in 50 mmol phosphate-bufferedsaline with a pH within the range of 7.4±0.2, at approximately 37° C.(to simulate body temperature).

Three crown devices underwent compressive strength testing, and allthree devices were subjected to creep resistance testing. Testingoccurred at an initial time point, at 3 days, 5 days, 7 days, 11 daysand at 14 days. For compressive testing, five new device samples wereused at each time point, totaling to 30 devices sampled. For creepresistance testing, each sample for each device was tested at every timepoint, and multiple samples of each device were tested (5 samples eachfor the crown shaped device and the Meropack device and 4 samples forthe Sepragel device).

In compressive strength testing, the force required to compress eachsample by 25% of the original nominal diameter of about 50 mm wasmeasured. To collect these measurements, each sample was held betweentwo plates with an initial separation of about 50 mm. The plates werethen moved together at a rate of 5 mm/min, and the force required forthe plates to reach a final separation of about 37.5 mm was recorded. Adevice was deemed to have passed the compressive strength test if itsstrength at 7 days was at least 25% of its initial value.

In the creep resistance testing, the samples of each device were placedinto models of ethmoid sinuses following functional endoscopic sinussurgery (FESS), each having a free floating middle turbinate representedby a free-floating, clear acrylic plate. The model dimensions (about 30mm in length, about 14 mm in height, and about 15 mm in depth) werebased on the average dimensions of a post-FESS surgery ethmoid sinus, asprovided in Lang J.—Clinical Anatomy of the Head: Neurocranium, orbit,craniocervical regions (Springer, New York 1981). The samples wereplaced such that they prevented the acrylic plates from contacting thebases of the models. At each time period, the distance between thebottom of the model and acrylic plate for each sample was measured inorder to evaluate the ability of the implant to support the freefloating middle turbinate. A device was considered to pass the creepresistance test if, at 7 days, the plate height was at least 50% of theinitial height (i.e., about 7 mm).

Table 1 shows the compressive strength of the device samples at thevarious testing points. Specifically, Table 1 shows the mean radialstrength for the sample test group at each time period, the standarddeviations of those strengths, and the number of fractures that occurredon that day. At 7 days, the devices retained 47.7% of their originalstrength, and thus all of the devices passed the test. At 14 days, fourof the five device samples had fractured, and thus no standard deviationcould be calculated for that test group.

TABLE 1 Compressive Strength (n = 5) Standard Number of Time Points Mean(N) Deviation Fractures Initial 0.01592 0.00164 0 Day 3 0.00812 0.001230 Day 5 0.00824 0.00089 0 Day 7 0.00759 0.00130 0 Day 11 0.00511 0.001051 Day 14 0.00438 N/A 4

Table 2 shows the creep resistance values for the various samples. Morespecifically, Table 2 shows the average plate height and thecorresponding standard deviation for each set of devices at each timeperiod. At 14 days, the devices still provided about 14 mm of separationbetween the free floating plates and the model bases, and thus all ofthe devices passed the creep resistance test. The Sepragel devicesyielded no separation at 3 days. The Meropack devices provided theirgreatest separations at 3 days, averaging 8.58 mm, but these separationsdiminished to an average of 1.28 mm at 14 days.

TABLE 2 Average Plate Height (mm) Time Points Sample Device SepragelMeropack Initial 14.13 ± 0.08 2.08 ± 0.32 3.14 ± 0.04 Day 3 14.11 ± 0.090 8.58 ± 1.21 Day 5 14.10 ± 0.15 0 8.15 ± 1.10 Day 7 14.12 ± 0.10 0 4.81± 2.08 Day 11 14.08 ± 0.06 0 2.29 ± 1.79 Day 14 14.05 ± 0.09 0 1.28 ±1.71

Drug Delivery

Crown shaped devices, as described above, were made having apoly(L-lactide-co-glycolide) filament with a lactide to glycolide ratioof about 10:90. Drug eluting coatings were formed containing mometasonefuorate, acetone, and poly(DL-lactide-co-glycolide) with a lactide toglycolide ratio of 70:30. One coating had no PEG, one coating had 5weight % PEG 6000, and another coating had 20 weight % PEG 6000. FIG. 12illustrates how the release of an agent can change with the addition ofa release rate modifier, in this case, polyethylene glycol.

The in vivo release of mometasone furoate was studied using a rabbitmodel. Crown shaped devices, as described above, were made having apoly(L-lactide-co-glycolide) filament with a lactide to glycolide ratioof about 10:90. Drug eluting coatings were formed containing mometasonefuorate, acetone, and poly(DL-lactide-co-glycolide) with a lactide toglycolide ratio of 50:50. One coating had no PEG, and the second coatingcontained 20 weight % PEG 6000. The crown shaped devices were implantedinto the maxillary sinus of the rabbits. The devices were then explantedat different time points. For each time point, the amount of mometasonefuroate remaining on the device was measured using a High PerformanceLiquid Chromatographic (HPLC) based assay. The release rate ofmometasone furoate was then calculated based on the amount remaining onthe device. FIG. 13 shows the in vivo release data, and demonstrates howthe release rate profile can be adjusted by changing the coatingformulation.

The in vitro release of mometasone furoate was studied using anaccelerated HPLC release rate assay. Crown shaped devices, as describedabove, were made having a poly(L-lactide-co-glycolide) filament with alactide to glycolide ratio of about 10:90. Drug eluting coatings wereformed containing mometasone fuorate, acetone, andpoly(DL-lactide-co-glycolide) with a lactide to glycolide ratio of50:50. One coating had no PEG, and the second coating had 20 weight %PEG 6000. FIG. 14 illustrates the cumulative release of mometasonefuroate from the two formulations.

We claim:
 1. A method of treating one or more sinus cavities comprising:advancing a device adjacent to a sinus cavity, wherein the devicecomprises a polymer at least partially coated with a drug eluting layer,the device degradable over a predetermined period of time and defining alumen therethrough, wherein the device comprises a single polymerfilament wound into a series of diamond shapes each comprising a peakand a valley, wherein a distal end of the device is defined by the peaksof each of the diamond shapes and a proximal end of the device isdefined by the valleys of each of the diamond shapes; delivering atleast a portion of the device within the sinus cavity such that at leasta portion of the device expands within the sinus cavity; and performingone or more procedures through the lumen.
 2. The method of claim 1,wherein the procedure is selected from the group consisting ofirrigating the sinus cavity, visualizing the sinus cavity, removing anexcretion from the sinus cavity, and delivering one or more drugs to thesinus cavity.
 3. The method of claim 1, wherein the device is advancedadjacent to the sinus cavity in a compressed configuration.
 4. Themethod of claim 1 wherein the device self-expands within the sinuscavity.
 5. The method of claim 1 wherein the device is expanded using anexpansion device.
 6. A method of treating one or more sinus cavitiescomprising: advancing a device adjacent to a sinus cavity, wherein thedevice has a first compressed configuration enabling low profiledelivery, and a second expanded configuration for apposition against atissue wall, wherein the device comprises a single polymer filamentwound into a series of diamond shapes each comprising a peak and avalley, wherein a distal end of the device is defined by the peaks ofeach of the diamond shapes and a proximal end of the device is definedby the valleys of each of the diamond shapes; and delivering at least aportion of the device within the sinus cavity such that at least aportion of the device expands within the sinus cavity.
 7. The method ofclaim 6 further comprising irrigating the cavity through the lumen. 8.The method of claim 6 wherein the device self-expands within the sinuscavity.
 9. The method of claim 6 wherein the device is expanded using anexpansion device.
 10. A method of treating one or more sinus cavitiescomprising: crimping a device from an expanded diameter to a compresseddiameter, wherein the ratio of the expanded diameter to the compresseddiameter is about 10:1; advancing the device adjacent to a sinus cavity,wherein the device comprises a single biodegradable polymer filamentwound into a series of diamond shapes each comprising a peak and avalley, wherein a distal end of the device is defined by the peaks ofeach of the diamond shapes and a proximal end of the device is definedby the valleys of each of the diamond shapes; and delivering at least aportion of the device within the sinus cavity such that at least aportion of the device expands within the sinus cavity.
 11. The method ofclaim 10 wherein the device self-expands within the sinus cavity. 12.The method of claim 10 wherein the device is expanded using an expansiondevice.
 13. A method of treating one or more sinus cavities comprising:advancing a device adjacent to a sinus cavity, wherein the device has asize and configuration adapted for implantation within one or more sinuscavities or ostiums thereof wherein the device comprises a singlepolymer filament wound into a series of diamond shapes each comprising apeak and a valley, wherein a distal end of the device is defined by thepeaks of each of the diamond shapes and a proximal end of the device isdefined by the valleys of each of the diamond shapes, and wherein thepolymer filament is wound into a loop at each peak and valley; anddelivering at least a portion of the device within the sinus cavity suchthat at least a portion of the device expands within the sinus cavity.14. The method of claim 13 wherein the device self-expands within thesinus cavity.
 15. The method of claim 13 wherein the device is expandedusing an expansion device.
 16. The method of any of claim 1, 6, 10, or13, wherein the one or more sinus cavities are one or more sinuscavities of a pediatric patient.